Regulatory Operations Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the regulatory operations job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

  • Craft your perfect resume by picking job responsibilities written by professional recruiters

  • Pick from the thousands of curated job responsibilities used by the leading companies

  • Tailor your resume by selecting wording that best fits for each job you apply

Noavatar-profile
CB
C Berge
Colby
Berge
79905 Alycia Fork
Chicago
IL
79905 Alycia Fork
Chicago
IL
Experience Experience
10/2015 – present
Houston, TX
Regulatory Operations Specialist
Houston, TX
Regulatory Operations Specialist
10/2015 – present
Houston, TX
Regulatory Operations Specialist
10/2015 – present
  • Work with OTC and Listed Derivatives Operations team to ensure daily calculation and filing of segregated amount, total asset on segregated deposits and residual interest are accurate and in compliance with Written Supervisory Procedures (WSP)
  • Provide oversight on LSOC Reconciliation and Reporting
  • Provide strategic input in order to shape and define efficient operating model which can support the process
  • Continually assess functions in terms of efficiency, adapting processes to increase effective implementation
  • Be the go-to person for queries from the business on any processing issues, escalating to management and compliance where necessary. Work to reduce risk on every level
  • Perform Risk assessments on functions performed by the team, ensure risks and control points are well documented and escalated
  • Support the regulatory reporting strategy project
10/2008 – 04/2015
San Francisco, CA
Regulatory Operations Manager
San Francisco, CA
Regulatory Operations Manager
10/2008 – 04/2015
San Francisco, CA
Regulatory Operations Manager
10/2008 – 04/2015
  • Represent CRS Quality and Compliance as a regulatory consultant at process improvement workgroups, institutional meetings, and conferences
  • Assist with developing and documents internal standards to ensure consistency across submissions, teams, therapeutic and functional areas
  • Working knowledge of the drug development process
  • Responsible for development and management of direct reports, and pro-active supervision
  • Manage resources, workload and budget for global publishing projects involving the EU RO Team
  • Partner with Consortium study teams to provide ad hoc regulatory management for ongoing clinical trials
  • Work on special projects, develop state or federal advocacy materials to be used by the state or federal Public Policy team
10/2001 – 07/2008
Los Angeles, CA
Regulatory Operations Operator
Los Angeles, CA
Regulatory Operations Operator
10/2001 – 07/2008
Los Angeles, CA
Regulatory Operations Operator
10/2001 – 07/2008
  • Assisting with the creation of several different monthly reports by providing data at an allotted point in time and assisting with compiling the end reports
  • Managing Level 2 potential OFAC Sanction & Embargo Escalation activities in the field Regulatory Filtering (Case Build & Decision Making)
  • Participating in Quality Assurance testing to ensure it is conducted on an on-going basis
  • Supplying requested data to auditors/regulators and responding to queries in a timely manner
  • Following up and closing out any items identified
  • Assessing and preparing responses for review of inbound Request for Information (RFI’s) & Client Due Diligence Questionnaire’s (DDQ’s)
  • Editing and preparing news and holidays for distribution within Deutsche Bank
Education Education
Bachelor’s Degree in Business
Bachelor’s Degree in Business
Rutgers University
Bachelor’s Degree in Business
Skills Skills
  • Knowledge of Quality System Regulation (21 CFR 820), ISO 13485, and other applicable Quality System standards
  • Strong interpersonal skills and ability to communicate effectively in both oral and written form
  • Detailed knowledge of the pharmaceutical industry and regulatory documents
  • Strong leadership, and project management skills and ability to manage many competing priorities
  • Highly motivated individual with outstanding record of professional achievement
  • Proficiency with standard business software including Microsoft Word, Excel, and PowerPoint
  • Prior experience in a federal regulatory agency with experience in operational risk, modeling or information technology, or legal experience on a broad array of regulatory operations issues
  • Strong computer skills in excel, word and power point
  • Advanced knowledge level of MS applications, which includes creating templates, editing and formatting complex documents in Word, PowerPoint, Visio, Excel, and Access
  • Detail orientedness and analytic abilities
Create a Resume
1

Regulatory Operations Analyst Resume Examples & Samples

  • Develops operational approach to accommodating regulations and guidelines; evaluates and summarizes rules and interpretations; creates action plan recommendations and ensures completion of plans. Monitors applicable regulatory agencies for rule changes and interpretations (via e-mail, internet, etc.). Periodically evaluates policies and procedures applicable to rules and guidelines
  • Represents Operations in partnership with department managers on communication with, but not limited to: regulatory agencies, internal compliance, internal and external auditors, legal, sales management and accounting-regulatory reporting. Acts as the key Operations contact for annual FINRA FinOp exam
  • Oversees firm possession and control issues as a Subject Matter Expert (SME) including, but not limited to: books and records, regulatory reporting adherence; technical knowledge required to ensure business information is correctly represented within reporting systems
  • Interprets, applies and recommends changes to organizational policies and procedures
  • Establishes objectives and develops processes and procedures to ensure efficient and timely work flow
  • Collects and analyzes information; interviews subject matter experts (SMEs), observes operations and uses knowledge of business systems and processes to develop solutions to specific problems
  • Develops an understanding of the regulatory requirements related to all projects, including the motivating factors for all stakeholders
  • Prepares project proposals and project plans
  • Assists in planning and implementing change initiatives
  • Ensures effective coordination occurs between assigned functional area and other areas
  • Identifies trends and implements corrective action as necessary
  • Financial markets and products and basic accounting principles
  • Application development and project life cycle methodologies and standards
  • Rules and regulations of the Securities Exchange Commission (SEC); Financial Industry Regulatory Authority (FINRA); and state securities regulatory agencies; and/or Federal Deposit Insurance Corporation (FDIC); Office of the Comptroller of the Currency (OCC); Office of Thrift Supervision (OTS); Federal Reserve System; and state banking regulatory agencies
  • Regulations of foreign countries as they pertain to securities
  • Making rule-based analytical decisions
  • Researching, interpreting and applying compliance-based policies and procedures
  • Integrating and aligning compliance processes and procedures with business processes
  • Implementing process improvement initiatives related to regulatory requirements
  • Understand and explain regulatory reporting requirements/standards for processes within Operations including, but not limited to: monthly/quarterly reconciliations, aged fails, open transactions, and client and firm receivables/payables
  • Perform complex calculations and/or analysis to determine regulatory exposure
  • Manage multiple individual projects that require research, consultation, and presentation of results and recommendations to internal and external audiences, including senior operations management and compliance management
  • Incorporate needs, wants and goals from different business unit perspectives into recommendations
  • Proactively execute assignments with little direct supervision
  • Maintain currency in securities and/or banking industry rules and regulations and best practices in compliance
  • Use appropriate interpersonal styles and communicate effectively, both orally and writing, with all organizational levels
  • Deliver presentations
  • Lead others in providing a high level of customer service
  • Incite enthusiasm and influence, motivate and persuade other to achieve desired outcomes without organizational authority
  • Bachelor's Degree and a minimum of six (6) years experience in compliance, risk management or operations in the financial services industry
  • Two years’ experience in SEC and FINRA regulations applicable to Broker-Dealer Operations
2

Operations Risk & Control Regulatory Operations VP Firmwide Operations Resume Examples & Samples

  • Customer Asset Protection Oversight
  • Regulatory Rule Change Management
  • Audits (Inspections)
  • Update stakeholders on current work drivers, achievements, significant issues and risks
  • Work with peers to improve operational processes and validate controls/procedures
  • Work with users to define and document current and future state processes
  • Create, review and validate controls and procedures
  • Knowledge of SSAE 16 auditing requirements
  • Experience co-ordinating/project managing SSAE16(SAS 70) audits
  • Knowledge of Wealth Management Operations, specifically Custody Operations
  • Adaptable to new processes and being able to coordinate multiple audits, where needed
  • 5-10 years of experience in designing and managing control functions in Financial Services/Banking industry
  • Prior experience with regulatory and governance programs a plus
  • Familiarity with Morgan Stanley Operations systems, processes, and framework a plus
3

Regulatory Operations Analyst Resume Examples & Samples

  • Aptitude for understanding the operational infrastructure model, front to back, across Operational divisions
  • Provide status updates to Operations Control Management on various initiatives
  • Develop ongoing relationships with the Operational support groups to understand current issues/challenges
  • Knowledge of CFTC, SEC, & FINRA Broker-Dealer rules & regulations preferred
  • Willingness to go the extra mile
  • BA required; Business or Accounting majors preferred
  • At least 2 years of relevant experience in Financial Services
  • Excellent Microsoft Excel and PowerPoint Skills
4

Regulatory Operations Associate Resume Examples & Samples

  • BA required
  • Minimum 3 years of experience in Financial Services
  • Policy and procedure writing
  • Rule interpretation and analysis
  • Ability to interface with Senior Operations Management
  • Strong Excel and PowerPoint Skills
5

Regulatory Operations Specialist Firmwide Operations Resume Examples & Samples

  • Resolution and Recovery Planning
  • Series 99 Co-ordination
  • Regulatory Reporting Projects
  • Demonstrate Teamwork and Project Management skills
  • Work with stakeholders to deliver assignments within deadlines
  • Understand, investigate, and escalate deficiencies in process implementation/oversight
  • Demonstrate Business Process Definition, Analysis, and Solution Design skills
  • Work with peers to improve operational processes
  • College is required with 4+ years of financial or consultative services; accounting or financial background is required
  • MS Office proficient; Excel proficient
  • Experience interacting with senior managers
  • High proficiency in written and verbal communications skills is required
  • Proficiency drafting complex documents is preferred
  • Comfortable with unstructured, changing environment; strong problem solving ability; knowledge of financial statements and ratios is required
  • Strong quantitative and qualitative skills with the ability to synthesize large amounts of data and deduce conclusions from data gaps
  • Ability to draw persuasive conclusions in PowerPoint presentations to executive management
  • Candidate is expected to work independently with minimal supervision and to develop into a highly trained professional with a well-balanced understanding of the company's range of activities
6

Regulatory Operations Specialist Resume Examples & Samples

  • Work with OTC and Listed Derivatives Operations team to ensure daily calculation and filing of segregated amount, total asset on segregated deposits and residual interest are accurate and in compliance with Written Supervisory Procedures (WSP)
  • Provide oversight on LSOC Reconciliation and Reporting
  • Ensure WSP are updated and provide effective controls to achieve compliance with legal and regulatory requirements
  • Provide strategic input in order to shape and define efficient operating model which can support the process
  • Communicate effectively with compliance to ensure current and new rules changes, laws and regulations are mapped appropriately and interpreted to support the development and enhancements of policies and procedures
  • Continually assess functions in terms of efficiency, adapting processes to increase effective implementation
  • Be the go-to person for queries from the business on any processing issues, escalating to management and compliance where necessary. Work to reduce risk on every level
  • Perform Risk assessments on functions performed by the team, ensure risks and control points are well documented and escalated
  • Support the regulatory reporting strategy project
  • Assist with the copulation of the Governance Deck and meeting minutes
  • Maintain and develop regulatory knowledge to serve as a subject matter expert and central point of contact for operations regulatory advice and interact with regulators as needed to provide information and responses
  • Support the development of programs and execute reviews on operational controls and the effectiveness of
  • Support systemic process and programs developed to address regulatory requirements
  • Identify and contribute to operational risk projects related to strategic business initiatives
  • An undergraduate degree in business, finance, other related fields
  • Candidate ideally needs to have strong knowledge of OTC Clearing and Futures product knowledge
  • A general awareness and experience of the impact of Regulatory reforms and how these reforms will impact the Industry
  • 4-7 years of related experience in the banking industry, compliance or regulatory
  • Material experience with operational risk disciplines; processes, risks and controls and familiarity with accounting systems/processes
  • Legal, Business, Accounting or Finance related postgraduate degree
  • Prior experience in a federal regulatory agency with experience in operational risk, modeling or information technology, or legal experience on a broad array of regulatory operations issues
  • Strong computer skills in excel, word and power point
7

Operations Regulatory Operations Regulatory & Monitoring Analyst Tokyo Resume Examples & Samples

  • Timely investigation and resolution of exceptions generated during the reporting process/ cycle
  • Coordinate the remediation of reporting anomalies
  • Recommend infrastructure and reporting improvements
  • Develop global partnerships across Operations, broader Federation and the business area in order to help implement initiatives
  • Maintenance of procedures and other documents relating to the team
  • Develop recommendations for process control improvements
  • Minimum 3 years of business experience in financial services
  • Experienced in working with complex financial products/functions including data analysis, information technology, business operating processes, and compliance
  • Experience in project management, risk management, or operations work including regulatory reporting
  • Strong interpersonal skills together with the ability to influence others and make decisions
8

Investment Risk Analyst Regulatory Operations Resume Examples & Samples

  • Support the Monitoring / Oversight of Risk Exposure
  • Support the daily e-mail notification process, which involves gathering information from a variety of sources and compiling it into a standardized form using an increasingly automated process that is then sent out via e-mail to a wide audience of interested parties
  • Support the preparation of regular liquidity risk assessments (including the preparation of necessary input files or reformatting output files) and the regular assessment of Fund shareholder registers as required, using both internally developed templates and external tools such as PwC ALLERT
  • Support the preparation of counterparty credit reports (including the generation of pie charts) for review and potential escalation if warranted
  • Support the preparation of risk dashboards using templates developed by the PAIR Reg Ops team (e.g. for a given risk entity such as TAML)
  • Support for the Monitoring / Oversight of Risk Exposure
  • Support for the Preparation and Submission of Regulatory Reports
  • Data Support for the Preparation of Risk Content
  • Support for the Preparation of Risk Management Process documents and Policies and Procedures
  • Assessment of Regulatory Documents, Summarizing key elements for further use to PAIR team, Compliance, Legal and Other Departments
  • Bachelor's degree, preferably in Economics or Finance. Progress towards CFA, CIPM, or other professional risk management designation favorably regarded
  • 1-2 years of work experience, preferably with some legal, compliance or risk management background
  • Good understanding of investment industry, particularly investment risk management and the use of financial derivative instruments in investment management. An education in finance is preferred, and strong quantitative skills are required
  • Superior knowledge of Word, Excel, PowerPoint required, including strong skills in Excel macros / VBA. Strength in Access and SQL also highly desirable
  • Demonstrated ability to communicate effectively both in writing and orally
  • Language skills: Fluency in Polish and strong English skills oral and writing are required. Knowledge of German is also strongly preferred
9

Operations Regulatory Operations Reg Reporting & Monitoring VP Jersey City Resume Examples & Samples

  • Writing functional specifications for technology for changes to reporting processes
  • Coordinating the testing and implementation of rule changes that impact reporting processes
  • Analysis of regulatory inquiries related to trade, transaction or position data
  • Recommending infrastructure improvemen
  • Develope recommendations for process control improvements
  • Experience in workflow and securities processing (5-7 years of industry or related experience)
  • Strong excel data analysis skills; MS Access or basic SQL skills a plus
  • Designing technical tools to support the reconciliation of exchange reports
10

Senior Regulatory Operations Representative Resume Examples & Samples

  • Guidance is received collectively as a team from HNAN Corporate Tax
  • Personnel have the authority to decision the validity of IRS customer forms received for processing
  • Proven and progressive branch and/or operational experience or equivalent
  • High school diploma or equivalent experience
  • Proven organizational and verbal/written communications skills
11

Regulatory Operations Regulatory Reporting Analyst Resume Examples & Samples

  • Prepare regulatory reports in compliance with existing regulations
  • Participate in projects related to regulatory reporting and provide insights and opinions as the relevant stakeholder
  • Deal with queries from regulators, management and other groups
  • Be aware of changes in the regulatory environment, new product developments and other important items
  • Basic knowledge of financial products
  • Capable to negotiate effectively with relevant stakeholders
  • Native level Japanese, business level English
  • Pays strong attention to details
  • Continues to work effectively and efficiently under ongoing pressure
  • Thorough understanding of Operations within securities
12

Regulatory Operations Manager Resume Examples & Samples

  • Minimum of eight years proven and progressive operations experience or equivalent
  • Proven management experience
  • Bachelor’s degree in business, related field, or equivalent experience
  • Strong managerial, communications, planning, organizational, decision-making, negotiations and project management skills
  • Strong knowledge of assigned businesses, products, operations, systems and full understanding of all applicable industry standards
13

Senior Associate, Regulatory Operations Resume Examples & Samples

  • Bachelor’s Degree desirable
  • 3 years of experience in Regulatory Operations and must be certified in InSight Publisher or be able to provide training completion certificates from Liquent
  • Basic computer skills in MS Office and Adobe Acrobat, experience with scanners and copiers, able to multi-task and set priorities, pay close attention to details, work in team environment
  • Computer skills in InSight Publisher and Acrobat plug-ins such as ISI Toolbox, ability to publish routine submissions
  • Work with functional areas to coordinate filings and have the knowledge and experience to publish more complex submissions
  • Uses professional concepts and company’s policies and procedures to solve a wide range of moderate problems in imaginative and practical ways
  • Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
14

Regulatory Operations Officer Resume Examples & Samples

  • Overseeing and ensuring the account exit process is timely, orderly and structured such that the bank is safeguarded against potential reputational, operational, regulatory or legal risk
  • Assist in quality assurance function for account closures completed by others, and receiving, logging and tracking incoming closing requests
  • Coordinating products exits with product areas to ensure timely exit
  • Proven and progressive branch and/or operational experience or equivalent
  • Minimum of an associate’s degree in business, related field or equivalent experience
  • Proven organizational, communications and analytical skills
15

Regulatory Operations Control Lead-ad Resume Examples & Samples

  • Manage The Control & Quality Management Team
  • Develop and execute the regulatory reporting strategy and target operating model across the U.S., including, but not limited to, the following
  • Control & Quality Management: Implement consistent and extensible control and quality management framework to ensure timeliness, completeness and accuracy of reporting
  • Management Reporting: Implement management reporting framework to measure and report performance; and
  • Toolsets: Implement centralized and robust toolset to provide increased tracking and communication
  • Manage front-to-back change management associated with regulatory reporting, such as rule identification and interpretation, execution strategy, communication, impact assessments and gap analyses, business requirements, education and training, and testing
  • Identify and implement regulatory reporting automation opportunities
  • Identify, analyze and resolve regulatory reporting issues
  • Facilitate communication with regulators and facilitate responses to regulatory requests and/or inquiries
16

Regulatory Operations Control & Change Department Manager Resume Examples & Samples

  • Oversee and supervise control and change management aspects of order, transaction and position reporting across U.S. Capital Markets and Wealth Management Operations
  • Manage two teams supporting regulatory reporting: The Business & Regulatory Analysis Team & The Control & Quality Management Team
  • Develop and execute the regulatory reporting strategy and target operating model across the U.S., including, but no limited to, the following
  • Organization: Centralize order, transaction and position reporting into U.S. Capital Markets Operations
  • Governance: Implement governance structure to provide oversight and leadership input on regulatory reporting
  • Technology: Partner with technology to develop and implement future state regulatory reporting infrastructure / architecture
  • Implement and manage overall control and quality management framework, including business scenarios, attributes inventories, rule inventories, test strategy development, test scenario development, test case and script development, quality testing, issue identification/analysis and resolution, control implementation and exception management
  • Identify industry alignment opportunities and strategy, and participate in regulatory reporting industry meetings such as SIFMA and the Financial Information Forum
  • Demonstrate strong people management skills sets and commitment to developing high performing, diverse teams
  • Demonstrate leadership across the region by contributing the regional strategy, developing people across the region, contributing to and participating in learning and development initiatives, and participating in citizenship and diversity initiatives
17

Regulatory Operations Specialist Resume Examples & Samples

  • Minimum 4 years of experience in electronic submissions and with eCTD
  • Minimum 1 year of experience in project management or in a team lead role
  • Knowledge of publishing software and tools used throughout the industry preferred
18

Project Manager for Regulatory Operations Resume Examples & Samples

  • Work experience in a business analysis / project management function supporting both business process and technology implementations
  • Proficient in Microsoft Word, Excel, PowerPoint, Project, Visio and SharePoint
  • Comfortable facilitating project working groups and possesses strong data gathering skills
19

Head of Regulatory Operations Resume Examples & Samples

  • 60%
  • Defines the glo bal and tactical strategy and governance of the Regulatory Operations team and manages updates accordingly
  • Ensures excellence in the global regulatory support to projects/products from inception through to end of lifecycle
  • Evaluates the global regulatory landscape and institutes changes that ensure Shire remains in compliance
  • Develops novel concepts and approaches to advance and/or challenge existing global regulatory paradigms
  • Effectively defines the Regulatory Operations resource
  • Works to centrally monitor resource allocations across GRAto align with the PRM and portfolio systems
  • Understands and manages internal and external relationships for the Regulatory Operations team
  • Partners with external contacts including professional scientific and regulatory groups, trade associations, product and software vendors and consultants to
  • Oversees the collaboration with IT to ensure resources are recruited and deployed as needed to support
  • Mentoring employees/consultants
  • Interviewing, hiring and training employees/consultants
  • Aggregating resource forecasts for projects/programs
  • Developing risk management plans and overseeing
  • Advanced degree in a science or technology or closely related field preferred
  • 15+ years of regulatory operations experience in the pharmaceutical/biotech industry
  • Generally has at least 10 years of management level experience
  • Experience in global drug development regulations, regulatory submission, lifecycle management, compliance, business systems technology, process, training and labeling is preferred
20

Regulatory Operations Production Reporting Team Senior Analyst Resume Examples & Samples

  • Produce and/or validate for accuracy daily, weekly or monthly regulatory reports including
  • Experience monitoring LOPR rejects and/or Electronic Bluesheets preferred
  • Strong proficiency in MS Word, Excel, PowerPoint and Outlook
  • Ability to identify process improvement opportunities and document requirements for automated solutions
21

Regulatory Operations Production Reporting Team Specialist Resume Examples & Samples

  • Bachelors Degree or Equivalent Required
  • At least 3 years of total experience in financial services
  • At least 1.5 year of experience with regulatory reporting or related support function preferred
  • Experience monitoring LOPR rejects preferred
  • Experience with some of the following reports is strongly preferred: LOPR, Short Interest, Reg Sho, Electronic Blue Sheets, Large Trader, ACT, INSITE
  • Experience speaking directly with regulators is preferred
  • Experience working with complex financial product / functions
  • Experience in control implementation, process improvements, project management, and/or change management preferred
  • Ability to maintain high standards despite pressing deadlines
  • Ability to solve problems quickly and efficiently
  • Demonstrated dependability and sense of urgency about getting results
  • Ability to build strong working relationships with people at all organizational levels
  • Ability to work well under pressure, adapt to unexpected events, prioritize and multi-task in a deadline driven environment
  • Must have excellent judgment, professionalism and integrity
22

Gto-regulatory Operations Team Lead-avp Resume Examples & Samples

  • Manage the Regulatory Ops team in Manila, covering the existing SDR function
  • Identify and minimise risk of Regulatory Reporting breach by analysing exception reports and ensuring control gaps are identified and addressed
  • Where an issue is identified, escalate to higher management in a timely manner
  • Co-ordinate efforts in implementing the changes to processes, system feeds, management information and workflow (including definition and acceptance testing)
  • Represent APAC in regional/global Regulatory calls and working groups
  • Manage the migration/transition of other incoming functions
  • Process ad-hoc support for requests from Front Office, Clients and other teams in GTO
23

Regulatory Operations Resume Examples & Samples

  • Provide oversight to Operations with regards to global regulations and when there are issues, work with the appropriate counterparts to solve the issue in a timely fashion
  • Assist improvements in the reporting system infrastructure, by means of creating test scenarios, and participating in user acceptance testing
  • Participates in global operations coordination calls and system enhancement discussions, and address the regulatory requirements and business needs associated with Japan
  • Interpret changes in regulatory requirements and communicate their impacts to Operations Control, senior Operation Managers and business partners where necessary
  • Maintain good business relationships with regulators and other global department
  • Middle Office or Operations experience
  • Quicker learner, who is self-motivated and can learn new products and systems quickly
  • Good awareness of global and Japanese regulations
  • Experience working within Regulatory Operations
  • Equity Product knowledge
24

Regulatory Operations Continuous Process Improvement Specialist Resume Examples & Samples

  • Understanding and defining the Transaction Reporting logic which exists front to back and how new rules and regulations impact Operations
  • Mapping the process plans for each of the proposed recommendations and working with the Lead Product Business Analyst’s to implement solutions
  • Maintaining reporting integrity and compliance by highlighting any gaps or errors in the systems or trade logic and actively looking to improve and / or develop them further
  • Acting as a key contact point for queries related to the project that may arise from both internal and external sources
  • Liaising with Programme / Project Managers and other stakeholders (on-shore, near-shore and off-shore) as appropriate as the business / functional counterpart for solution identification or execution
  • Supporting the design and conceptualisation of new business solution options and articulating identified impacts and risks
  • Supporting Senior Management in delivering the status of assigned projects and prioritising change requests
  • Being responsible for the Quality Assurance of project deliverables from the expected requirements perspective
  • Designing tactical solutions to issues where strategic options are not available
  • Participating in Project meetings and / or constructing and co-ordinating the production of Management Information, highlighting the updates, issues and risk to Senior Management and other key stakeholders (Product / Global Tracking System Management, Regulatory Groups, Compliance, Audit etc.)
25

Regulatory Operations Support Officer Resume Examples & Samples

  • Act as a point of contact in all jurisdictions for branches, functional and business units such as TSC, BSC, Business Banking, Personal Banking and the non bank units to assist with the tracking and resolution of relevant Regulatory related queries via the established mailboxes and the FATCA Tracking System (FTS)
  • Escalate unresolved queries for guidance to the Tax Authority Group, Compliance or other parties as required
  • Act as a point of contact for FATCA related matters from RBC Canada, IRS and other applicable stakeholders
  • As a hub for RBCC jurisdictions, ensure the generation of letters to relevant clients and the maintenance of client communication data through the use of the FATCA Tracking System and other relevant databases
  • Track and respond to external requests for FATCA related information including but not limited to correspondent banks and regulators
  • Create and support reporting to management and other partners including but not limited to performance management and dashboard reporting and reports on controls
  • Ensure compliance with Regulatory reporting requirements
  • Keep abreast of all relevant Regulatory requirements, policies, processes and procedures and assess impact to ensure risk identification and risk mitigation
  • Ensure the review, update, development and implementation of applicable Policies, Processes and Procedures
  • Support project related activities as required
  • Review and remediate files for applicable clients for all jurisdictions and businesses based on RBC Global AML Program Client Risk Scoring Methodology and the KYC Minimum Standards
  • Periodic review and remediation of files for applicable clients for all jurisdictions and businesses on an ongoing basis
  • Ensure the proper maintenance of client files and other auditable records
  • Participates in Performance Management through regular reviews, on-going coaching discussions of the PEAD and Development Plan
  • Associate Business Degree or equivalent relevant qualifications
  • At least 3 years’ working experience in Banking Operations or Compliance Operations
  • Working Experience in a Client Facing environment will be an asset
  • Working knowledge of Microsoft Office
  • Detail oriented with the ability to grasp information quickly
  • Must have a basic knowledge of business functions
  • A Team Player
  • Good analytical/critical thinking skills
  • Good organizational skills with the ability to meet deadlines and multi-task
  • Creative problem solving and good research skills
26

Regulatory Operations Officer Resume Examples & Samples

  • Carry out daily production processes in order to make sure the firm meets all regulatory reporting requirements
  • Handle and give oversight of reporting exceptions by coordinating with various regional reporting teams accordingly on a daily basis
  • Build relationships and coordinate with all departments from Front to Back (ie. FO, IT, Compliance, Operational Risk, etc.) as necessary
  • Become involved in improving current system infrastructure for long term strategic development
  • Interpret changes in regulatory requirements and communicate their impacts to Operations Control and the management where necessary
  • Be responsible for and maintain full competency in ensuring all regulatory requirements are met from all regulatory bodies that is applicable to the business
  • Good Operations experience with extensive cross product knowledge
  • In depth understanding of financial markets, trade and clearing, cash and derivative products in the scope of operations
  • Excellent understanding of Japanese regulation especially in terms of regulatory reporting
  • Able to adapt and deal flexibly with any changes
27

Regulatory Operations Business Analyst Resume Examples & Samples

  • Experience in an Operations Control Environment
  • Strong interpersonal skills together with the ability to influence others and make decisions
  • Experience with regulatory reporting
  • Working knowledge of tradable financial products, e.g. equities, fixed income, exchange traded derivatives, OTC derivatives
28

Director Regulatory Operations & Controls Resume Examples & Samples

  • Leadership - Provides strategic and tactical direction to the team by
  • Operational Management & Improvement - Leads the execution of operational strategies and plans
  • Expert knowledge of regulatory initiatives such as BSA/AML, FATCA, Dodd Frank
  • Excellent written and verbal skills required to prepare communications and interact effectively with other Bank
29

Regulatory Operations Resume Examples & Samples

  • Minimum education; Bachelor's degree
  • Research and analytical skills with the ability to summarize complex findings
  • Attention to detail and organization skills
  • Experience working within a financial institution
  • Ability to conduct independent verification of reporting data
  • Excellent analytical skills and the ability to consult and resolve issues related to data extraction, validation, report generation
30

Regulatory Operations Director Resume Examples & Samples

  • An undergraduate degree or equivalent combination of education and applicable professional experience
  • Highly motivated individual with outstanding record of professional achievement
  • Strong interpersonal skills and ability to communicate effectively in both oral and written form
31

Assoc Regulatory Operations Specialist Resume Examples & Samples

  • 1 year of experience in a corporate environment
  • B.A. in scientific, technical, or engineering
  • Experience in a medical device or regulated industry
  • Advanced Microsoft Office Skills: Visio, Project, and other software platforms
  • Experience with document management systems such as Documentum
  • Project management experience and/or certification
  • Strong interpersonal, oral, presentation, and written communication skills
  • Ability to understand end-audience needs and requirements
  • Ability to work collaboratively and across groups
  • Strong analytical problem-solving skills
  • Advanced Microsoft Office Skills: Excel, Word, and Outlook
32

Regulatory Operations Manager Resume Examples & Samples

  • 6 years regulatory experience or Master’s degree with 4 years regulatory experience, including experience with pre-market submissions
  • 2 years of experience providing work direction and leadership to people and teams
  • Experience with Regulatory Operations activities in other industries, such as pharmaceutical industry
  • Ability to work effectively across functions and at different levels within the organization
  • Ability to effectively manage multiple projects and priorities
  • Experience with PLM systems and processes
  • Experience with regulatory information management systems & distribution controls
  • Experience managing implementation of regulatory system and publishing
  • Experience with process harmonization and governance across different organizational units
33

Regulatory Operations Manager Resume Examples & Samples

  • 5+ years’ regulatory experience
  • 3+ years of experience providing work direction and leadership to people and teams
  • Prior project management experience a plus
  • Bachelor’s Degree in Information Technology, Engineering, Regulatory Science, Life Sciences, Communication, Business or related medical/scientific field
  • Demonstrated Leadership Capability
  • Knowledge of worldwide medical device regulations and regulatory requirements, such as FDA medical device regulations, EU Medical Device Directive, Canadian or Japanese medical device regulations
  • Excellent written and verbal communication, technical writing, and editing skills
  • Demonstrated advanced software skills including Microsoft Word, excel, database (i.e. RAD/Documentum) and Adobe software skills
  • Excellent Project-management skills and experience
  • Ability to be flexible with changing priorities
  • Experience in regulation of medical devices or experience working with medical device
34

Regulatory Operations Associate Resume Examples & Samples

  • Coordinate, QC, prepare, and publish documents for inclusion in regulatory submissions (INDs/ NDAs/ DMFs/ MAAs). Ensure compliance with the FDA and international regulations/ guidelines/ best practices
  • Format and publish regulatory submission documents to ensure that they meet the company’s style and publishing guidelines. Apply appropriate Word styles/ templates, spell-check & proofread as needed, format tables
  • Provide support and technical assistance for formatting of regulatory submission documents
  • Prepare and QC PDF documents for submission using ISI Toolbox (bookmarking, hyperlinking, auditor)
  • Perform routine submission publishing activities associated with electronic and hard copy submissions
  • Ongoing maintenance of submissions (including supplements/ amendments/ annual reports/ responses to FDA review letters & requests for information). Tracking and archiving of regulatory filings and correspondence for specific drug programs. Audit and QC periodically to maintain compliance
  • Ensure regulatory timelines are properly established, maintained, and on-target. Track regulatory project status and provide updates as needed to RA/ management/ project teams/ vendors
  • Assist in preparation of meeting materials for regulatory agency meetings
  • Skilled in time management, project management, oral & written communication
  • Self-motivated, self-confident, comfortable working with minimal supervision
  • Team player who is resourceful, creative, energetic, and results-oriented
  • Ability to accept and integrate input from diverse sources and work effectively across multi-disciplinary work teams
  • Must enjoy working in a fast-paced environment
35

Director, Regulatory Operations Resume Examples & Samples

  • Secures publishing and dispatch services according to agreed timelines for regulatory submissions of new developments and marketed products such as NDAs, INDs, CTAs, PSURs, Variations, Responses to Health Authorities, etc. and, thus, is responsible for ensuring global submissions life cycle management for the Pacira product portfolio in order to reach Pacira business goals
  • Develops and implements strategy to convert all Pacira US FDA applications to e-regulation compliance by 2018 as per FDA requirements
  • Provides leadership and guidance for all submission management activities within Pacira
  • Organizes document management processes with external vendors such as CROs and with third-party companies for cooperation projects
  • Provides consulting for document authors in technical document questions and formal process issues of document creation according to the corresponding report SOPs
  • Develops, sets-up and maintains a long-term archiving strategy and solution, including a retention policy for regulatory relevant documents (US and globally)
  • Directs the development, establishment and maintenance of an integrated planning and tracking database system containing key data on regulatory events and the documentation submitted in each country
  • Develops and oversees processes to ensure coordination of global submissions between Pacira and development/commercialization partners globally
  • Ensures global coordination of planning data and the maintenance of schedules for submissions such as NDAs, CTAs/INDs, PSURs, changes/variations etc. as being set-up by the respective Clinical Regulatory Lead
  • Develops processes, procedures, methods, and templates to create, maintain and update Company Core Data Sheets (CCDS). Oversees the creation and maintenance of CCDSs for all Pacira Products
  • Ensures coordination of global labeling based on CCDSs with development/commercialization partners globally
  • Develops processes, procedures, methods, and templates to create, maintain and update the Package Insert and other labeling and packaging in the US and other regions in which Pacira has responsibility for product labeling
  • Bachelor degree in physical or life sciences from accredited college or university required. An advanced degree in a technical field of study is preferred
  • Minimum of 8 years of regulatory experience in the pharmaceutical industry; previous regulatory operations and/or labeling experience preferred
  • Minimum 5 years experience interpreting and applying industry regulations to specific projects (FDA and ICH or other regulatory agency guidance requirements)
  • Strong demonstrated understanding of regulatory requirements
  • Hands on experience with Electronic Document Management Systems
  • Recent, hands on experience with the tracking, compilation, publishing and submission of US INDs and NDAs. Experience working with submissions to regulatory agencies outside the US is preferred
  • Demonstrated knowledge of global (US, EU and ICH) regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues
  • Excellent written and oral English communication skills
  • Demonstrated keen attention to detail
  • Proven strong organizational skills with ability to set priorities and meet deadlines
  • Demonstrated negotiating- and problem-solving skills
  • Sound working knowledge of writing and publishing computer applications
  • Proven ability to communicate well with colleagues at all levels of the organization
36

Director, Regulatory Operations & Compliance Resume Examples & Samples

  • Lead the development labeling material through cross-functional collaboration according to agreed timelines and established processes
  • Tracks compliance with Global Labeling processes, eg, implementation of CCDS information into product labeling, identifies issues and defines escalation needed
  • Manages QMS Continuous Improvement and Monitoring effort from Regulatory Affairs Vaccines perspective, including activities such as procedure authoring, review, and content maintenance of the QMS
  • In coordination with QMS stakeholders, ensures compliance-related issues are identified and resolved
  • Liaises with Global Labeling and authors new agreements when needed in collaboration with the Global Labeling Lead, tracks and monitors compliance to Labeling Agreements
  • Establishes and manages relationships with Takeda business partners and Affiliates to ensure label control, efficient label creation and continuous improvement of programs to meet business needs and regulatory requirements
  • Leads planning, execution, and management of regulatory compliance projects in support of regulatory submissions for in various phases of clinical development, global marketing applications, and post-approval life cycle activities, as needed
  • Evaluate and implement within VBU electronic system for distribution, review and approval of advertising and promotional materials
  • Provides operational support to Global Labeling activities
37

Senior Associate Regulatory Operations Resume Examples & Samples

  • Defines submission outlines, content, format, and quality requirements for electronic submissions, with input from Regulatory Affairs staff. Facilitates submission preparation via completion of forms, creation of cover letters, etc., as required. Represents Regulatory Operations on project teams for matters relating to electronic (and paper) submissions. Archives all incoming and outgoing communications with FDA and international counterpart agencies. Develops and supports the development, refinement, and implementation of internal processes, procedures, work instructions and training programs for submission production and operational support activities. May specifically provide training to colleagues and teams. Participates in implementation, validation, and operation of eCTD and electronic document management systems and other publishing and submissions technology projects, e.g., FDA Electronic Submissions Gateway, HL7 stability data, publishing software evaluations and implementation. Develops submission compilation timelines in accordance with Company and project goals, in collaboration with RA Liaison staff and project teams. Manages the activities of external staff contracted to compile and publish major electronic submissions (e.g., eCTDs, NDAs); set standards and priorities. Participates on the project/ regulatory submission team and provide clear and consistent regulatory recommendations Coordinates and consults with other departments on the content, review, and assembly of regulatory documentation. The RA Associate will ensure consistency, completeness, and adherence to standards for all regulatory submissions. Assists in the development and review of labels/labeling (including product labels, Instructions for Use and marketing literature). Assists in the creation of regulatory project plans and timelines for multiple projects or developmental programs. Maintains up-to-date knowledge of regulatory agency guidance and requirements. Manages data compiled and presented by vendors. May build and maintain internal databases relating to submissions compilation and tracking
  • 5+ years’ experience in a fast-paced, high-volume document production environment (e.g., documentation, publications, electronic publishing) or clinical environment, preferably in the biotechnology/ pharmaceutical industry or another health care industry
  • Experience with an eCTD publishing system such as GlobalSubmit
  • Requires a detail-oriented self-starter with excellent organizational, planning, and follow-up skills, as well as communication, teamwork, interpersonal and strong leadership skills
  • Ability to lead project teams in the development of new processes as required by FDA regulations
  • Ability to meet tight competing deadlines, juggle multiple priorities and multi-task
  • Experience with Adobe Acrobat, document scanning, and electronic document management (Documentum, SharePoint or equivalent) highly desired. Knowledge of MS Excel, MS Word, MS Project Acrobat and/or ISI Toolbox is helpful
38

Regulatory Operations Manager Resume Examples & Samples

  • Hold and control the global database for all licences, leases, permits relating to aviation
  • Maintain a master list of when all these documents are due for renewal
  • Record and maintain a list of personnel responsible for renewal of these documents
  • Producing notification dates for all documents based on the length of time it procedurally takes to renew
  • Produce and keep up to date the regulatory requirements and procedure for renewal
  • Agree with sites locally how original copies are to be stored and archived
  • Ensure all original documentation is audited
  • Produce and own the procedure for renewal within WFS. Whilst not conducting the renewal will ensure it moves in a timely and accurate manner
39

Manager of Regulatory Operations Resume Examples & Samples

  • Knowledge of scientific, medical, and regulatory terms
  • Knowledge of GCP
  • Written and oral skills
  • Skilled in Microsoft Office software, including Word, Excel, and Access; high computer literacy and ability to learn new software if required
  • Strong leadership and ability to organize workload for staff
  • Ability to multi-task in fast paced environment is essential
  • Ability to manage, organize, and make decisions
  • Five years direct regulatory experience or equivalent experience
40

Regulatory Operations Specialist Resume Examples & Samples

  • Assist in the review, authoring, and compilation of tabulated and written summaries needed for preparation of required components for IND submissions
  • Maintain regulatory timelines and eCTD tracking information coordinating completion of required components of IND by other contributing team members
  • Lead a regulatory-specific EDMS transition and subsequently be responsible for system updates and maintenance
  • Collaborate with contributing functional areas to assure adequate prioritization, scheduling, preparation and dispatch of regulatory submissions
  • Work with outside regulatory information management companies to ensure a quality final submission and meet internal deadlines
  • Bachelor’s degree in life science, regulatory science, or related field
  • Five (5)+ years in pharma/biopharma regulatory, with a minimum of one (1) to two (2) years’ eCTD experience
  • Experience with biologics/gene therapy is preferred
  • Medical writing experience is preferred
  • Ability to understand and execute on the company’s mission and values
  • Exceptional organization skills with strong attention to detail
  • Strong personal leadership and self-direction
  • Clear communication in both oral and written form
  • Demonstrated ability to work with and coordinate demands from multiple stakeholders
  • Exhibition of the highest degree of ethical standards and trustworthiness
  • Advanced skills in Microsoft Word, Adobe Acrobat Professional®, and regulatory publishing applications including Veeva Vault, and StartingPoint™ Templates
41

Global Regulatory Operations Associate Resume Examples & Samples

  • Works closely with contributing functional departments to ensure handoff of submission components in the appropriate format per established submission-ready guidelines and handoff procedures. Responsible for the preparation, compilation, quality check and delivery of regulatory submissions in both paper and/or electronic format in accordance with regional requirements and company standards
  • Participates on project teams as appropriate for assigned projects and/or submissions
  • Assures completeness and quality of submissions from the technical and operations perspective. Coordinates final internal review and approval of submission output before dispatch to health authorities
  • Responsible for archiving of regulatory submissions documents and supporting information, Health Authority correspondence, and contact reports
  • Participates in User Acceptance Testing (UAT) (running scripts, taking screenshots, etc.) for implementation and updating of various GRO systems
  • Supports Global Regulatory Affairs (GRA) systems end-users, including troubleshooting and training
  • Assists with creating/updating GRO SOPs, work instructions and job aids
  • Maintains regulatory relevant databases such as: Alexion Global Submission Planner (GSP), Global Registration Status (GRS) tracker, etc
  • Assists with various activities related to migration of legacy content between repositories
  • Participates in pilot projects, tools evaluations and vendor selection
  • Participates in preparation of GRO newsletters and other communication pieces, as needed
  • Performs some administrative activities, as assigned by management
  • 3-4 years of experience in biopharmaceutical industry or related sector, with 2-3 years in Regulatory Operations
  • Solid experience using Microsoft Office (Word, Excel, PowerPoint, Visio & Outlook), and Adobe Acrobat/Toolbox. Experience with MS Project and SharePoint is a plus
  • Knowledge of global CTD/eCTD structure and requirements is desirable
  • Experience with eCTD publishing and validation tools is a must
  • Good experience with authoring templates and eCTD Viewing tools
  • Experience with electronic document management systems (Documentum, FirstDoc, Veeva, etc.) and records management standards, a plus
  • Strong oral and written communication and interpersonal skills
  • Strong project management and organizational skills
  • Experience working with large spreadsheets, SP lists and databases, and prior data entry and verification experience is desirable
42

Global Regulatory Operations Associate Resume Examples & Samples

  • Support Regulatory team in planning, publishing, submission, and archive of regulatory documents
  • Ensures compliant, high-quality, timely submissions in accordance with current and emerging Health Authority guidance across multiple regions
  • Work across company disciplines and represent Regulatory Operations on assigned project and/or task teams to effectively communicate timings and deliverables
  • Format documents intended for regulatory submissions in accordance with company style and ICH Guidance documents to ensure they meet requirements for electronic submissions and optimal global utilization
  • Prepare and publish documents for global regulatory submissions in “electronic Common Technical Document” (eCTD) format, including, but not limited to: amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc
  • Assist in the maintenance of document standards, templates, and procedures related to the formatting, publishing and archiving of both electronic and paper submissions according to company regulatory standards
  • Minimum of Two years of Regulatory Operations experience
  • Direct experience with publishing, compiling, preparing and QC of documents for eCTD submissions
  • Demonstrates a working knowledge of electronic document management systems (EDMS) and publishing technologies. Experience with Global Submit Product Suite, ISI ToolBox, and Starting Point templates a plus
  • Ability to work independently with moderate supervision on multiple projects simultaneously
  • Detail oriented with creative problem solving and troubleshooting skills
  • Exceptional interpersonal skills with the ability to work individually and within multi-disciplinary teams
  • BS/BA or equivalent industry experience
43

Regulatory Operations Quality Assurance Manager Resume Examples & Samples

  • Developing the quality assurance processes, ensuring they are fit for purpose, whilst fostering an environment in which continuous improvement is at the forefront of the agenda for the team
  • Taking responsibility for the Department and/or the team’s performance, against agreed Service Level Agreements (SLAs), Key performance Indicators (KPIs) & Key Risk indicators (KRIs)
  • Producing both regular and ad hoc Management Information (MI), analysis and insight to clearly display progress to targets
  • Acting as a subject matter expert of the reporting infrastructure and the associated processes, and creating an environment in which all team members seek to attain the same
  • Managing and maintain knowledge transfer, with the aid of training plans and matrices
  • Acting as the first and second level escalation contact for the team, from both internal and external escalation matters
  • Performing root cause analysis on issues/incidents experienced and ensuring that appropriate solutions are implemented into existing procedures
  • Creating, managing and owning all aspects of the Risk and Control profile and framework for the group
  • Ensuring that the team’s processes are fully compliant with any applicable regulation, and that all required control processes whether directly related to processes or in terms of overall control, are fit for purpose and maintained without exception
  • Taking ownership and providing oversight to the performance of controls within the Department and/or team, ensuring they are complete, timely, and accurate
  • Taking responsibility for control and mandate validity, implementing strategies to ensure regular review, continuous process improvement and correct evidencing
  • Highlighting operational, regulatory and other risks to Senior management and departments such as Regulatory, Compliance and audit
  • Taking ownership to identify key issues and actively participating in their resolution, to ensure client satisfaction and acceptable business outcomes
  • Building and maintaining relationships with internal Deutsche Bank Partners, to provide a point of contact within the team for time critical, complex or regulated tasks in particular
  • Contributing to, driving and cascading the strategic direction of the Division, providing leadership and direction to management, Supervisors and Operators and oversight to functional and/or product teams to ensure that processes are in line with all internal/external policies/guidelines and requirements of the regulators
  • Understanding, translating, communicating and applying business strategies and objectives, ensuring that direct reports and functional teams are aligned to the overall strategy and objectives
  • Understanding articulating and implementing best practices related to your product expertise
  • Building and fostering an environment in which company values, ethical framework and diversity are at the centre of decision making and applied in our approach to business solutions
  • Acting as a role model and promoting a culture of high performance, in relation to the values and beliefs, ensuring that through effective People Management that employees are effectively supported
  • A Bachelors degree, or the equivalent technical experience or qualifications
  • An understanding of trade processing and a proven performance and control record
  • An understanding of the main asset classes and/or a regulatory background (beneficial)
  • A prior understanding of trading lifecycle, banking regulatory environment and relevant products
  • Strong experience within auditing/investment banking (beneficial)
  • An excellent team worker who collaborates across silos and functions
  • Strong analytical, interpersonal, and organisational skills
  • Excellent computer skills including practical use of Microsoft Word, and Excel
  • The ability to manage multiple tasks/issues and prioritise accordingly
  • Previous people management experience
  • Experience of managing other managers (beneficial)
  • A Strong leader and team player, able to work with your main team creating a good team working environment
  • A proactive individual who is able to create a culture of challenge and innovation for team
  • Extremely organised and able to cope with competing demands and priorities
  • A strong people management focus showing great leadership skills
44

Regulatory Operations Associate Resume Examples & Samples

  • Submissions include Clinical Study Reports, protocols & amendments, CMC supplements, nonclinical updates, investigator brochures, safety reports, meeting briefing documents, annual reports, advertising and promotional materials (OPDP)
  • 3-5 years' experience in a biotech and/or pharmaceutical environment and a minimum of 2 years direct regulatory experience with multiple regulatory filings including but not limited to INDs and NDAs
  • Experience in electronic submissions in eCTD format & PDF publishing
  • Knowledge of regulatory requirements governing drug trials, manufacturing and regulatory applications, including those for investigational and marketed products in the US and Europe
  • Bachelor's Degree in a scientific discipline or equivalent experience is required
  • Proficient in Microsoft Word, Acrobat
  • Experience with StartingPoint eCTD templates and macros and/or ISI Toolbox preferred
  • Library Veeva Vault and EndNote experience helpful but not required
45

Senior Manager, Regulatory Operations Resume Examples & Samples

  • This position will oversee submission planning (including scheduling and resource allocation), formatting, publishing (including QC), transmitting and archiving regulatory submissions in both paper and electronic media to health authorities in the US, EU, CA and Rest of World
  • This position will manage internal Regulatory Operations personnel as well as the activities of external consultants
  • The position will also oversee the development and maintenance of processes, templates, standards, and guide sheets
  • The position must be able to oversee applications and systems support (including Livelink Knowledge Management), systems training programs, and supporting development projects within Regulatory Affairs. Other duties as assigned
  • This position interacts with Regulatory Affairs and departments providing information to be submitted (including but not limited to Clinical, Nonclinical, and Quality)
  • This position requires extensive knowledge of MS Office, Adobe Acrobat, Livelink and InSight Publisher
  • This position requires the ability to exercise discretion, independent judgment and clearly identify priorities, as well as to work overtime in order to meet required timelines
  • At least 4 years of experience in Regulatory Operations OR at least 3 years of experience in Regulatory Operations, InSight Publisher certification, and 2 years of related experience
  • Minimum 2-3 years of direct management experience required
  • Must be highly proficient in MS Office 2013 (with an emphasis on MS Word) and Adobe Acrobat (version XI Pro preferred). Strong knowledge of eDMS and eCTD Publishing Systems (Livelink and InSight Publisher preferred). Must have extensive experience with electronic submissions, specifically eCTD
  • The candidate should have proven ability to manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience managing major regulatory submissions, with the ability to successfully manage projects to deadlines
  • The candidate is expected to have a thorough understanding of relevant submission formatting, transmittal and archiving regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities. Must be able to interpret guidelines and effectively implement
46

Manager, Regulatory Operations Resume Examples & Samples

  • Responsible for maintaining compliance with all laws and regulations applicable to HSI business models and operations
  • Develop and implement systems and procedures to research and monitor current regulations and new legislation at the Federal and State level
  • Responsible for maintaining and enhancing the processes and systems in place for the receipt, storage and distribution of controlled substances, list 1 chemical
  • Develop appropriate compliance awareness training programs and conduct training for different areas as needed
  • Develop and implement systems and procedures to ensure compliance with Hazardous Materials, and OSHA requirements
  • Ensure TSMs are appropriately trained to handle Hazardous materials in order to prepare safe domestic and international shipments of these products
  • Develop and implement policies and procedures to ensure the safe storage and disposition of hazardous waste and ensure compliance with all applicable Environmental regulations
  • Monitor changes to regulations, legislation, guidance documents and policy to determine impact to the Company and subsidiaries
  • Oversee government inspection activities including inspectional observations as well as corrective action plans
  • Interface with regulatory agencies (FDA, DEA, State BOP, DOT, OSHA, EPA, etc.) and review/approve changes to company policies and procedures
  • Oversee the activities to secure and maintain proper company licensure and product registration as needed to supports HSI Operations and Business Units
47

Senior Regulatory Operations Specialist Resume Examples & Samples

  • Experience in information systems, software development, business analysis or other related field within regulated industry
  • Business Analysis, Lean Six Sigma, and/or Project management professional (PMP®) certification
  • Strength in strategic and systems-thinking; able to understand the connections between multiple systems and processes and chart an efficient path through them
  • Experience in project management in a matrixed environment
  • Knowledge of data management principles and best practices, e.g., SQL
  • Knowledge of 21 CFR Part 11, systems validation methodologies, HIPAA, and FDA regulatory requirements
  • Experience with ECTDs (electronic common technical documents)
  • General understanding of software and information technology solutions and experience matching solutions with client needs
  • Innovative problem solving skills with the ability to identify problems, drive to root cause, develop, and implement solutions independently or as part of a team
  • Experience in process development and improvement and the ability to recommend the best solution with the highest process improvement impact
  • Self-motivated to make recommendations and initiate assignments that will improve business processes and systems
  • Successful at building trusting, collaborative working relationships as a team lead and team member
  • Track record of results achievement balanced with ability to compromise when needed
  • Excellent organizational skills and attention to detail and accuracy
  • Excellent written and oral communication ability, including presentation skills
  • Able to stay flexible with changing priorities and remain calm under pressure in a dynamic environment
48

Regulatory Operations Specialist Resume Examples & Samples

  • Perform verification of regulatory data against source documents
  • Coordinate the collection of data for the PMR business
  • Assist with the resolution of outstanding data issues
  • Pulling manufacturing documents (drawings, artwork, formula sheets) from various systems
  • Track overall progress of data collection and verification
  • Update source systems with verified regulatory data
  • Attend weekly project meetings
  • Provide support during GTS go-live.Search Jobs US
49

Product Safety & Regulatory Operations Internship Resume Examples & Samples

  • Assisting the organization with the demands of processes and projects in the Regulatory Area
  • Generating statistical reports, data and presentations to Management, as well as the regional and global Board
  • Assist in the assembly product registration processes
  • Assist in activities for service providers
  • Assist in various administrative activities
  • Students with availability for 2-year contract from the following careers: Environmental Engineering, Biology, Agronomy, Veterinary Medicine, Pharmacy and Biomedicine
  • Basic knowledge of Office package (Excel, PowerPoint, Word)
  • Intermediary English
  • Availability to stage 6 pm daily
  • Excellent communication and relationship skills
  • Persistence and dynamism
50

Senior Regulatory Operations Leader Resume Examples & Samples

  • A key responsibility will be to drive and manage all aspects of planning and publishing submissions and/or submission components including all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, production (paper and electronic), and archiving (paper and electronic), as applicable
  • Responsible for maintaining and tracking of regulatory milestones and deliverables and ensuring excellence in the global regulatory support to projects/products throughout lifecycle management
  • Drive continued process improvement and operational excellence by developing and initiating standard processes related to regulatory submissions. This can include developing or revising templates, and developing processes /procedures to ensure compliance with global regulations
  • Interprets local and global electronic submission regulations and prepares interpretative analyses of key regulatory guidance documents related to submissions
  • Bachelor's Degree in science related field or regulatory affairs required
  • Minimum 7+ years’ experience in life sciences/biotechnology industry required, with 5+ years’ experience in global Regulatory Affairs Operations with increased responsibility/leadership
  • Prior experience managing regulatory operations function and personnel strongly preferred
  • Hands-on experience and extensive knowledge of IND/BLA/eCTD and other electronic requirements and guidelines required
  • Experience with Structured Product Labeling (SPL) submissions and technology required
  • Experience in working with vendors in support of BLA and marketing authorization application submissions outside US
  • Experience in gene therapy or rare disease preferred
51

Director Regulatory Operations Resume Examples & Samples

  • Technology:Selects the appropriate technology and vendors to deliver and support solutions and requirements for the changing landscape of submissions. Supports and understands the impact of standards and requirements. Executes the strategic roadmap of aligning systems with a global impact. Responsible for regulatory submission process improvements and establishing repeatable processes utilizing key technologies. Creates and maintains submission timelines using planning tool/software
  • Strategy and Initiatives:Provides input on optimal submission strategy for the company. Leads and actively engages external and internal initiatives. Leads communications with external partners and health authorities. Advises on submission strategy and takes part in project team meetings. Assists in the writing of departmental SOPs
  • People:Advises others within Regulatory as well as various associated departments. Provides leadership and manages Global Submission or Dossier Planning function. Leads and oversees the strategic implementation of outsourcing services were applicable. Leads Submission Team meetings
  • Submission Team Leadership/Group Facilitation:Drives strategic and tactical decisions regarding regulatory filings. Responsible for timely submission of high quality regulatory submissions in all formats. Manages the submission process from initiation through to approval and dispatch for major Regulatory submissions (IND, NDA, Agency Responses, others). Supervises managers who will oversee the day-to-day submission activities and or Dossier Team for global project. Manages and leads a highly trained and skilled team. Develops individual career development path and assists team members with their own development. Provides guidance/training to the Submission Teams on internal document submission standards and processes
52

Regulatory Operations Specialist Resume Examples & Samples

  • 2-4 years regulatory/clinical experience at a medical device company or 3+ year(s) related experience and training
  • Microsoft applications, which includes working with templates, and editing and formatting complex documents
  • SAP/GTS experience
  • Flexible with priorities and responsibilities
  • Effective organizational skills and attention to detail
  • Regulatory or quality department experience
  • Works well under pressure in a dynamic environment
  • General knowledge of industry practices, techniques and standards
53

Regulatory Operations Specialist Resume Examples & Samples

  • Knowledge of Quality System Regulation (21 CFR 820), ISO 13485, and other applicable Quality System standards
  • Experience with database management and accessing document management systems
  • Experienced in performing Quality System assessments of manufacturing facilities, and demonstrated proficiency in implementing Quality System corrective actions
  • Lead Auditor certification for ISO 13485 from an accredited agency preferred
  • Must work well in team environments and demonstrate leadership skills in team setting
  • Excellent written and verbal communication skills
  • Experience developing and presenting quality training to internal customers
  • Experience in the medical device industry preferred
  • Must be capable of interacting with all levels of management
  • Learns quickly when facing new problems, open to change and enjoys working to find solutions
  • Fluency in local language required
54

Wroc-regulatory Operations Strategist Resume Examples & Samples

  • Provide clear Regulatory direction and assessment to factories and markets in relation to requirements and factory change initiatives or queries
  • Market Requirements delivered to factory RFT
  • Factory dossier delivered to market on time
  • WROC Systems Maintained accurately and up to date
55

Regulatory Operations Manager Resume Examples & Samples

  • Review changes to FCC price cap rules and the impact on CTL's price cap modeling
  • Prepare data analyses related to regulatory rules changes or for data requests
  • Work on special projects, develop state or federal advocacy materials to be used by the state or federal Public Policy team
  • Prepare FCC Tariff Review Plans
  • Work on special pricing issues related to Wholesale Contracts
  • Maintain, develop and verify data extracts used by Regulatory Operations for analyses and reporting
  • Serve as the subject Matter Expert in certain areas of regulatory rules including the transaction from written rules to model algorithms
  • Interact with Federal and State Utility Commissions
  • Prepare written data requests and responses or other Commission Requests
  • Work on state or federal USF issues as required
  • Bachelor's degree or equivalent in traning and experience
  • Minimum 5 years experience in a Regulatory, Wholesale or Finance support environment
  • Advanced knowledge of Microsoft Excel, including creation of model
  • Programming experience in FOCUS, SQL, Visual Basic or other languages
  • Working knowledge of CAB/IABs billing systems, Ensemble and CRIS
  • Working knowledge of Wholesale Market Products and telecommunications industry and governing regulation
  • Working knowledge of Regulatory and Regulatory data requirements Background in regulatory/legislative process and issues
56

Regulatory Operations Publisher Resume Examples & Samples

  • Gathering, organizing and archiving data and documents required in the drugs registration process
  • Finalising the submissions of technical data for Ministry of Health/Competent Authorities around the world
  • Use of Internal and External Publishing Tools
  • Bookmarking and hyperlinking of regulatory documentation for submission to the multiple regulatory agencies
  • Responsible for reading and learning external guidance documentation
  • Daily contact and interaction with peers in a team environment as well as with team leaders
  • Minimum bachelor’s degree (life sciences specialisation is preferred)
  • Excellent English language skills (verbal and written)
  • Understanding and basic experience in MS Office tools, Acrobat, and Windows
  • Ability to identify problems/issues and follow directions to solve/resolve problems
57

Senior Associate Global Regulatory Operations Resume Examples & Samples

  • Work as part of a global Regulatory Operations team, contributing to global filings
  • Lead key submissions for EU, Switzerland and Emerging Markets
  • Compilation and publishing of submission dossiers for Europe and the emerging markets for clinical trials, paediatrics and marketing applications
  • Work closely with submission content providers to advise on submission content, structure, planning and strategy
  • Work with publishing vendors
  • Regulatory submission source document review, formatting, & troubleshooting, including but not limited to, MS Office, Adobe Acrobat PDF, Acrobat Plug-ins and XML ensuring documents conform to style guide and internal/external regulations
  • Preparation of submission ready components from source documents according to regional regulatory agency guidance
  • Document management of ongoing submissions, e.g. building dossier structure, sourcing documents
  • Quality control of submission ready components and submission dossiers
  • Preparation , dispatch and tracking of electronic and paper media
  • Maintenance of submission information in Regulatory Registration Tracking system
  • Degree or equivalent combination of experience and knowledge
  • Demonstrated regulatory publishing experience within the pharmaceutical industry
  • Advanced knowledge of MS word and Adobe Acrobat
  • Use of specialist publishing software to prepare submissions – Insight Publisher preferred
  • Use of electronic document management systems
  • Understanding of Regulatory submission requirements
58

Sourcing Legal & Regulatory Operations Manager Resume Examples & Samples

  • Manage and collaborate positively across Enterprise Supply Chain, Risk and Legal teams and with internal clients to develop and implement regulatory and legal programs
  • Be the Sourcing representative, execute and co-ordinate the Sourcing deliverables in projects such as Resolution Planning, General Data Protection Regulation, Bail In, Modern Slavery, Brexit and other EU/Global related regulatory requirements
  • Support the Sourcing team with the expired contracts process in the region
  • Ensure a clear understanding of all Citi policies and procedures that directly impact sourcing. Drive the adoption and adherence to these processes and procedures to minimize risk. Work with the regional and country sourcing teams to ensure that regional policies and procedures mitigate risk in the procurement process and provide suitable control and guidance to all sourcing staff. Support process and procedure updates
  • Own the delegation of authority, purchase order and contract signing limit process for the region
  • Assist in all sourcing audits and audit deliverables. Assist in Management Controls Assessments testing and remediation
  • Assist with opening and closing Corrective Action Plans within EMEA Sourcing
  • Own the Supplier Diversity and Sustainability Initiative within the region
  • Manage the collection and analysis of supplier, contract and spend data related to the regulatory and legal projects, produce and own the relevant trackers
  • Manage the relationship with the General Services team regarding items such as Records Management, Archiving and Mailroom
  • Manage the relationship for Enterprise Supply Chain with internal and external Legal Counsel on projects and Contract related matters
  • Achieve ESC and job related specific goals
59

Regulatory Operations Associate Resume Examples & Samples

  • Working in matrix environment
  • Working in Teams
  • Familiarity and successful submission and maintenance of CTN, eCTD, NDA, and Regulations in Japan
  • Communication skills in Japanese and English
  • English conversation, read, and writing
  • Computers: Microsoft Outlook/ Word/ Excel/Power Point/Project
  • Over 5 years experience in regulatory affairs or regulatory operations with experiences for supporting PMDA consultation, CTN, and NDA submission of pharmaceuticals in Japan
  • Graduate University or Collage
60

Regulatory Operations Associate Resume Examples & Samples

  • Image quality control
  • Transformation Concatenation
  • Bookmarking
  • Hyperlinking
  • Identifying Issues
  • Initial Regulatory Operations Reviews
  • Use of MS Office programs and Internal and External Publishing Tools
  • Following all internal standards including Standard Operating Procedures, Guidance Documents and Policies throughout the submission lifecycle
  • Reading and learning external guidance documentation related to electronic submissions such as FDA Guidance documents or ICH guidance
  • Completion of assigned tasks with a high degree of quality in a timely manner
  • Being prepared to deploy on site to support eSUB (electronic submission) projects
  • Taking instruction and perform tasks as necessary as directed by reporting manager
  • Document level quality control
  • Assisting with Accenture's internal development projects
  • Minimum 1 year general professional experience
  • Minimum 1 year experience in MS Office tools, Acrobat, and Windows
  • Aptitude towards learning new processes and technologies
  • Interest in performing work that is repetitive in nature and willing to produce the proper quality and quantity of work under these conditions
  • Professional written and oral communications skills
  • Ability to identify problems issues and follow directions to solve resolve problem
  • Experience working in a team based environment
  • Ability to be flexible and adapt to change
  • Ability to share and impart knowledge with others
61

Product & Regulatory Operations Intern Resume Examples & Samples

  • Mapping current product commercialization processes
  • Identifying stakeholders CTQ requirements along the order fulfillment cycle
  • Evaluating and maintaining right-to-operate and product compliance processes
  • Identifying and executing on opportunities for process improvement
  • Blueprinting of next-generation processes for use by database design teams
  • This is a nation-wide posting. Relocation and Housing are not supported
  • Enrolled in a degree program in Chemistry, Chemical Engineering, Polymer Science/Engineering, Material Science, Operations Management, Management Information Systems, or related field
  • 1-2 years’ experience working with cross-functional teams
  • Knowledge of Microsoft Office, Sharepoint 2013 preferred
  • Experience with IBM® Lotus® Notes preferred
62

Senior Manager Regulatory Operations Publishing Resume Examples & Samples

  • Lead and develop regional publishing team to deliver regulatory dossiers for the EU and ROW region
  • Liaise with other regional Regulatory Operations teams to deliver global filings
  • Drive improvement and implementation of tools, methodologies and processes within regional and global teams
  • Contribute to submission strategy and timings as part of cross-functional team
  • Build Relationships with Industry Working Groups and Agencies
  • Represent functional expertise on global teams
  • Lead information system and software update projects
  • Manage vendors, consultants and/or staff to execute work activities, manage projects, programs or a function
  • Participate in the development of processes, policies, guidelines, SOPs, & Training Manuals
  • Strong track record of Pharmaceutical/biotech industry experience in an operationally focussed role within Regulatory Affairs
  • Line Management Experience
  • Working in cross-functional teams
  • In-depth understanding of Regulatory submission requirements and processes
  • Use of publishing tools and document management systems
63

Regulatory Operations Analyst Resume Examples & Samples

  • Monitors daily securities possession or control requirements to ensure compliance with the Customer Protection Rule (15c3-3); proactively communicates deficits and any identified issues to the LOBs in order to reduce firm deficits
  • Compiles and reviews regulatory reporting information used for Weekly Reserve and Monthly FOCUS reporting; ensures that reporting information is compliant with applicable industry regulations (e.g. 15c3-3, 15c3-1)
  • Monitors operational suspense and clearance accounts, inventory, and dealer accounts to ensure compliance with firm accounting policies/industry regulations; escalate identified issues to Supervisor/Manager and the relevant line of business
  • Assists and provides input in the interpretation of new/changing securities rules, regulations, policies or laws; updates processes for compliance to rules and regulations as well as departmental procedures
  • Compiles operational account information for internal and external auditors (e.g. FINRA, SEC) with limited oversight
  • Plans and executes remediation efforts for any identified issues with minimal guidance/support from Supervisor/Manager; assists the Manager or Senior Analyst in formalizing milestones needed in order to implement corrective action plans for any identified issues
  • Identifies opportunities for operational efficiency and productivity improvements to mitigate financial, reputation and regulatory risk; suggests solutions to Supervisor/Manager
  • Assists Manager or Senior Analyst in the design, planning, and execution of testing strategies; under direct supervision, may lead the testing efforts of other analysts; communicate any issues to management that require immediate attention in a clear and concise manor; draft recommendations to mitigate risk
  • Assists in the development and coordination of periodic operational performance reports/scorecards for Management, including trend analysis and recommended strategies
  • Participates on projects
  • Brokerage operations and how functions performed by Operations Control align with business partners
  • Brokerage industry and financial markets
  • Accounting principles/concepts
  • Conducting quality control reviews for functions performed within Operations
  • Creating procedure and business process workflow documentation
  • Executing training materials/programs
  • Executing test strategies, methodologies and analysis
  • Operating standard office equipment and using required Microsoft Office (Excel, Access, PowerPoint) and other software applications
  • Support efforts in the evaluation or implementation of a control or process
  • With minimal guidance, interpret financial/brokerage rules, regulations and security laws; ensure all industry rules, regulations, and security laws that apply to a process are correctly followed
  • Manage multiple tasks with changing priorities; meet deadlines in a fast paced environment with constant interruptions; adapt to a constantly changing environment
  • Bachelor’s Degree (B.A.) in related field and minimum of two (2) years’ experience in the areas of accounting, banking and/or financial services
64

Senior Regulatory Operations Analyst Resume Examples & Samples

  • Leads the work of others and provides training in possession or control requirements to ensure compliance with the Customer Protection Rule (15c3-3); proactively communicates any identified issues and/or possible solutions to the LOBs in order to reduce firm deficits
  • Reviews and submits regulatory reporting information used for Weekly Reserve and Monthly FOCUS reporting; ensures that reporting information is compliant with applicable industry regulations (e.g. 15c3-3, 15c3-1); serves as a liaison between Regulatory Reporting and Brokerage Operations to define and clarify reporting requirements
  • Monitors operational suspense and clearance accounts, inventory, and dealer accounts along with performing account risk analysis to ensure compliance with firm accounting policies/industry regulations
  • Interprets new/changing securities rules, regulations, policies or laws; leads efforts in updating processes for compliance to rules and regulations as well as updating departmental procedures with little to no guidance from Supervisor/Manager
  • Leads efforts in researching and compiling operational account information for internal and external auditors (e.g. FINRA, SEC) with little to no guidance from Supervisor/Manager
  • Plans and executes all aspects of remediation efforts for any identified issues with minimal guidance from Manager; formalizes the milestones needed in order to implement corrective action plans for any identified issues; owns and drives the action plan for any opportunities/gaps identified
  • Identifies opportunities for operational efficiency and productivity improvements to mitigate financial, reputation and regulatory risk; leads efforts to implement solutions with little to no guidance from Supervisor/Manager
  • Leads other analysts in the planning and execution of testing strategies with minimal guidance from management; escalate any findings, issues and guidance to Management; drafts recommendations and leads further discussions around guidance provided in a clear and concise manor
  • Leads in the development and implementation of periodic operational performance reports/scorecards for Management, including trend analysis and recommended strategies
  • Leads project teams with minimal guidance from Supervisor/Manager
  • Financial industry rules, regulations and laws relating to processes performed by Operations Control
  • Regulatory terminology, concepts, and guidance
  • Concepts, practices and procedures for testing operational systems/processes
  • Conducting quality controls reviews for functions performed within Operations Control
  • Evaluating processes/systems and identifying risks and controls; recommending appropriate actions/revisions to resolve any identified gaps or mitigate risk
  • Developing and coordinating production of periodic operational risk performance reports/scorecards for Management, including trend analysis and recommended strategies
  • Designing and implementing training materials and programs for both his/her team and supported LOBs
  • Proactively engage, collaborate and influence business partners in the adoption of identified opportunities to create or enhance a control or process
  • Lead project teams with minimal guidance from his/her manager, drive consensus, and resolve conflict
  • Interpret financial/brokerage rules, regulations and security laws
  • Provide a high level of customer service
  • Bachelor’s Degree (B.A.) in related field and a minimum of three (3) to five (5) years’ experience in the areas of accounting, banking and/or financial services
65

Established Products & Regulatory Operations Manager Resume Examples & Samples

  • Accountability for the execution of all relevant critical evaluation of data, assessment and advance identification of issues, preparation of project plans for own assigned projects and supporting planning and evaluation by direct reports for their projects
  • Responsible for efficient compilation, filing and negotiation of life-cycle management submissions within time lines specified by Corporate Office or local Management
  • Leading the interactions between Canadian/International BI personnel as well as the Canadian Health Authority with respect to the Regulatory Operations and other related activities (e,g, ATI requests,electronic submissions,RI process, Comments on Regulations and Guidelines, Annual DIN Notification, Commitments tracking,etc...)
  • 2)Regulatory intelligence
  • Utilizing publicly available resources and information to provide Regulatory Competitive Intelligence to support local strategies and maximizing our business potential
  • Monitor changes to Regulatory environment (regulations, guidelines, policies, etc.) and communicate impact locally and globally
  • Participate in the training of Drug Regulatory Affairs (DRA) staff
  • 3)Coordinate and supervise the execution of the department operational workload plans for Established products and all submissions for New and Development Products
  • Ensure the Operations team executes all deliverables and functions, meeting or exceeding requirements for timeliness, and accuracy as well as meeting department standards for productivity, quality and compliance
  • University degree in a scientific field (B.Sc) required, advanced post-graduate degree is an asset (M.Sc.)
  • Post-Graduate RA/QA Certificate is an asset
  • Demonstrated experience in Regulatory Affairs in the Pharmaceutical Industry
  • Excellent leadership, organization, time management, and written/verbal communication skills
  • Strong attention to detail and solid Project Management skills
  • Strong analytical aptitudes, skills and capacity to assess and summarize scientific data and regulatory situations
  • Excellent INTERNET and publications research skills
  • Strong technical knowledge of the Canadian Food & Drugs Act and Regulations,
  • Good understanding of Quality related functions is considered an asset
  • Strong knowledge of CMC regulations and Canadian policies/guidelines (TPD, ICH); good knowledge of other regions regulatory environment (FDA & EMEA)
  • Computer skills (i.e. MS Office,Outlook, PowerPoint, Word, Excel, Adobe Suite, electronic submissions (eCTD))
  • Team player, able to multi-task under tight deadlines and work with minimal supervision, ability to work on multiple projects at one time
  • Exceptional interpersonal skills, ability to interact with key stakeholders
  • Strong problem solving and issue resolution skills
  • Strong negotiations skills
66

Manager Regulatory Operations Dossier Planning Resume Examples & Samples

  • Education: Bachelor’s degree in Life Sciences, or equivalent experience, is essential
  • Experience in the pharmaceutical industry with at least four to six years regulatory operations experience. High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers is required. Past experience in regulatory submission planning is a plus. Working knowledge of drug laws, regulations and guidelines is essential
  • Competencies: A thorough knowledge and understanding of Health Authority regulations, guidance documents and the drug development process is required. The ability to plan and manage multiple, complex dossier plans simultaneously is required. Self-sufficient, self-motivated, excellent leadership skills, able to prioritize and delegate, detail-oriented, good interpersonal skills, ability to effectively communicate in writing and orally with peers and upper management.Advanced computer skills (MS Word, Excel, Project and Adobe Acrobat) are vital. Understanding of templates and authoring tools is a plus
  • Electronic publishing experience – e.g., InSight Publisher, ViewPoint, eCTD Reviewer, Documentum, etc. is a plus
67

Regulatory Operations Operator Resume Examples & Samples

  • Keep all operational guidelines updated and ensure adherence to standards, procedures and also identify risk mitigants wherever there is a control issue
  • Ensure “Zero” processing error in all the areas under control
  • Ensure adherence to all cut-off times
  • Ensure quality and quantity of processing is maintained as per the SLA (Specify minimum SLA parameter)
  • To ensure that messages/payments are released in a timely manner
  • To escalate any process related ambiguities to their respective supervisors or manager for clarification
  • Knowledge of the different applications used to process messages of different regions
  • Ensure adherence to Operating procedures
  • Knowledge of both electronic and manual payment processing
  • Contribute to innovation
  • Ensure proper knowledge has been acquired for the backup functions (self)
  • To carry out the responsibilities of an PS in his/her absence
  • Assist DBOI GS Pvt Ltd., Bangalore in carrying out any special tasks or projects that may be required from time to time as assigned by Team Manager by fully adhering to the procedure laid down in the corresponding Procedure documents and following all the necessary regulations and guidelines
  • Escalate all issues properly, in time, to the appropriate level, to avoid any adverse impact on the business
  • 1year of Cash Operations experience
  • SWIFT Knowledge viz. Interface, Clearing system, Message Type
  • Ability to work independently, as well as in a team environment, prioritize multiple tasks and meet strict deadlines
  • Must be prepared to work in a shift in line with regions supported including India night shifts (as per business requirements and as decided by the Manager / AVP)
  • Must be prepared to work on weekends and (Indian) public holidays (as per business requirements and as decided by the Manager / AVP)
  • Basic understanding of the business and Cash Operations
  • Good understanding of Fund Transfer and Embargo process
68

Regulatory Operations Operator Resume Examples & Samples

  • Managing and completing remote due diligence exercises for Deutsche Bank’s agent / nostro bank network globally which seeks to identify, assess and mitigate market, custodian and operational risk. This includes issuance, review of responses, assessing, capturing risks and creating summaries
  • Monitoring identified risks and updating tracker on a regular basis
  • Reviewing existing Service Level Agreements (SLAs) with operations and agent / nostro banks
  • Implementing new SLAs when required
  • Completing weekly review of credit risk ratings, and liaising with relevant Deutsche Bank Credit officers when there is a change
  • Obtaining approvals from Credit Risk Management as part of annual Due Diligence reviews
  • Assisting with renewal of Power of Attorneys (POAs) and other legal documents
  • Tracking all legal documents
  • Monitoring email inbox
  • Editing and preparing news and holidays for distribution within Deutsche Bank
  • Monitoring inbox and addressing operational queries raised by Deutsche Bank operations and agent / nostro banks responding in a timely and appropriate manner
  • Handing over pertinent items to relevant geographical regions at appropriate time
  • Escalating items to management as necessary
  • Assessing and preparing responses for review of inbound Request for Information (RFI’s) & Client Due Diligence Questionnaire’s (DDQ’s)
  • Assisting with the creation of several different monthly reports by providing data at an allotted point in time and assisting with compiling the end reports
  • Distributing reports to internal clients
  • Supplying requested data to auditors/regulators and responding to queries in a timely manner
  • Tracking open audit points
  • Participating in Quality Assurance testing to ensure it is conducted on an on-going basis
  • Following up and closing out any items identified
  • Ensuring all market and agent information is maintained and updated across appropriate databases and regulatory sites
  • Updating/re-certification of operational procedures
  • Experience in any of the following disciplines: Network Management, Broker / Dealer operations, Custody, Audit, Compliance, Securities / Cash Operations, Payments or Client Services
  • Knowledge or understanding of regulatory obligations
  • Ability to manage tasks across a large number of internal and external stakeholders
  • Ability to working within an international team in a rapidly changing environment
  • Strong attention to detail and task-oriented
  • Ability to resolve open issues conclusively
  • The ability to analyse concise and accurate reports
  • The ability to provide written communication with agent banks concerning often-sensitive relationship issues in an appropriate manner
  • An understanding of custody & cash products and the associated operational requirements
  • In depth knowledge and understanding of industry initiatives, developments and their implications to the organisation
  • Educated to Degree level or relevant industry experience
69

Regulatory Operations Manager Resume Examples & Samples

  • Process and publish IND and IST safety reports
  • Assist with IND lifecycle maintenance including scheduling and tracking of submissions
  • Meets aggressive deadlines to ensure that regulatory agencies receive high-quality and timely submissions
  • Primary contact for publishing outsourcing partner
  • Communicates with external authors/contributors on Array’s publishing requirements and ensures consistency in external vendor produced documents and deliverables
  • Assist with managing RIM software, including data migrations
  • Support RIMs data entry, maintenance and Reg Affairs team
  • Communicates with and advises development teams on publishing requirements, as well as maintaining focus and awareness of potential delays, problems, gaps of information, expectations, project steps, milestones and deliverables
  • Assist with developing and documents internal standards to ensure consistency across submissions, teams, therapeutic and functional areas
  • Has thorough understanding of domestic and international regulations and guidelines and is capable of interpreting the intent of the regulations and guidelines
  • Proactively and independently researches and communicates potential regulatory operations issues that could streamline the development process for a project
  • Builds strong working relationships within the department and cross-functionally as well as business partners
  • May assist with training others on publishing, RIMs software and Array internal procedures
  • 5 years’ experience in Regulatory Operations publishing or equivalent in biotech, pharma, or medical device
  • 5 years’ experience with RIMs and electronic submission software
  • Experience working with regulatory agencies
  • Must be “hands-on” and willing and expected to take on projects and tasks to support the team
  • Solid understanding of the processes and interactions essential for the production of regulatory submissions
  • A strong communicator with excellent verbal and written communication skills
  • Able to implement and manage projects
  • Demonstrates leadership potential
  • Strong functional experience in Regulatory Operations with previous success working on cross-functional project teams
  • Applies solid technical knowledge of regulations and guidelines in order to assess applicability of a document
  • Proficient in understanding the timelines and processes for submissions and shares knowledge with team members
  • Solid knowledge of the assembly and compilation of complex submissions and publishing and electronic submission software
  • Working knowledge of the drug development process
  • Understands external guidance documentation related to paper and electronic submissions
70

Senior Manager, Regulatory Operations Resume Examples & Samples

  • Prepare,coordinate, manage, and/or maintain regulatory submissions (e.g.,INDs, CTAs, amendments, safety reports, DSUR/annual reports, meeting packages, etc.) in accordance with applicable regulations. This includes the ability to translate regulatory requirements into practical, workable submission plans; develop and maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival)
  • Provide regulatory support for operations activities
  • Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance, or other departments
  • Review and communicate current and emerging regulatory requirements (e.g., US and international regulations and guidelines)
  • Author and review standard operating procedures (SOPs);ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts
  • Electronically publish INDs and IND amendments
  • Effectively manage the Regulatory Operations Associate to meet department goals and encourage personal growth and productivity
  • Bachelor’s degree in a scientific discipline or 10+ years of regulatory documentation and operations experience
  • Regulatory Affairs Certification is preferred
  • Solid understanding of FDA regulations and ICH guidance as well as comprehension of the drug development process
  • Excellent Computer Skills in Word, Excel, Power Point, and Acrobat
  • Familiarity with eCTD publishing software
71

Regulatory Operations Specialist Resume Examples & Samples

  • Manage and maintain first in human and phase 1 trial regulatory documents for sponsor or FDA inspection; creation and maintenance of relevant articles in EndNote reference library per scientific indication; creation and maintenance of sponsor data rooms for due diligence and licensing
  • Manage and maintain all regulatory documents for industry-sponsored clinical drug trials, such as paper IND submissions, FDA briefing books, Regulatory Site Binders, clinical study reports, new drug applications, common technical documents, and marketing authorization applications
  • Liase with client Subject Matter Experts in Chemistry, Manufacturing and Controls (CMC) to perform QC checks of CMC documents regarding the Investigational Medicinal Product; communicate issues with external global project leads regarding FDA submissions
  • Create, review, assemble and manage client deliverable documents and submissions using standard word processing systems and utilities (ISI Toolbox, Word, Adobe Acrobat, etc)
  • Log and track regulatory documents, publications and other relevant materials that pertain to project deliverables and deliver client information/documents, as appropriate
  • During FDA audits, function as primary source of document retrieval to ensure correct and complete documents are provided to auditors
  • Coordinate team activities to ensure timelines for expedited 7- and 15 day safety reports are submitted to Regulators, external to MGH
  • Primary ownership of Trial Master Files for Sponsors; liase with external vendors to obtain required trial related documents for audit readiness
  • Ensure correct hyperlinking and formatting in submissions in a hosted eCTD environment
  • Ensure efficient processes and timeline adherence for the submission of IND, ANDA documents including handling issue logs
  • Prepare Partners IRB submissions, amendments and continuing review applications in Insight. Prepare universal IRB protocols for country-wide IRB review
  • Assemble Trial Master Files for project closeouts
  • Maintain revision control and tracking for controlled documents
  • Maintain required regulatory submission calendar
  • Bachelor's Degree required with relevant industry experience, advanced degree preferred
  • RAC or TOPRA certification preferred
  • 2+ years' directly related and progressively more responsible experience
  • Previous hands-on experience with the paper and eCTD processes with the compilation of INDs and ANDAs, including Amendments and Supplements with the FDA
  • Prior experience in the preparation and submission of documents using regulatory/document management systems
  • Experience working in multidisciplinary project teams with knowledge of the drug development process and drug regulation as relates to regulatory submission operations
  • Knowledge of and experience in document-level formatting and publishing
  • Understanding of the CTD structure as well as FDA and ICH specifications for eCTD submissions
  • Detailed knowledge of the pharmaceutical industry and regulatory documents
  • Ability to work independently and under pressure (able to prioritize tasks, deadline oriented, good organizational and problem-solving skills, follow-up skills) with accurate and meticulous attention to detail
  • Detailed understanding of clinical trial management from a sponsor perspective
  • Proficiency with standard business software including Microsoft Word, Excel, and PowerPoint
  • Detail orientedness and analytic abilities
72

Regulatory Operations Specialist Resume Examples & Samples

  • Coverage of GTS for Neurovascular Products
  • High attention to detail, highly skilled in task management, task oriented
  • Ability to solve problems and provide solutions
  • Effective organizational skills
  • Intermediate/Advance knowledge of word processing, spreadsheet/graphing, including knowledge of MS Office applications, including Word, Excel, PowerPoint
  • Experience in a regulatory affairs, either in regulatory product specialist, regulatory international or regulatory operations role
  • Working knowledge of document management systems (e.g. Agile, RAD, Documentum)
  • SAP experience
  • Project work associated with SDLC, Data Warehousing, Data and Process Improvement
  • 3+ years of experience in related fieldSearch Jobs US
73

Regulatory Operations Specialist Resume Examples & Samples

  • Independent oversight of Vendor Invoices to ensure accuracy
  • Responsible for managing the financial relationship between Global Business Management, FIS, State Street, Pershing and Head of US Ops
  • Optimize end to end processes
  • Drive overall RTB target down
  • Plan, forecast and report financials
  • Monitor and analyze budget and cost control
  • Support departmental initiatives associated
  • Create and develop senior management presentation to provide regular updates
  • Coordinate contract amendments and renewals with stakeholders
  • Review regulatory mandates and ensure vendor contracts are updated, as needed
  • Coordinate with PICS COO Centralized Team
74

Regulatory Operations Associate Resume Examples & Samples

  • Performs submission activities, including, but not limited to, formatting and publishing electronic documents, ensuring submissions are built with submission-ready documents, creating inter-document links, QCing and validating compiled submissions, and submitting by target date
  • Generally supports INDs, IND amendments, BLAs, BLA supplements, CTAs, MAAs, and/or MAA variations
  • Provides guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
  • Collaborates with vendors who support Regulatory submission related tasks
  • Assists with developing and maintaining Regulatory submission publishing standards and procedures in accordance with all applicable Regulatory regulations, guidance, and specifications
  • May support archive activities as needed
  • Identifies and communicates regulatory system enhancement needs or technical issues
  • Provides support and backup to management as needed
75

Associate, Regulatory Operations, Pros Resume Examples & Samples

  • Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumation, pagination, and formatting of reports and simple submissions
  • Under supervision perform basic document management tasks including file transfer, storage, tracking, and archival
  • Develop a familiarity with current global regulatory submission standards
  • Appreciation of global regulatory submission formats, industry standards, and guidelines, software validation concepts, and publishing best practices
  • Proficient in Microsoft Windows environment including, but not limited to, Microsoft Office products; and Adobe Acrobat
  • Problem-solving, time management, analytical, adaptability, listening, and negotiation skills
  • Ability to work independently and in a team environment with supervision
  • Strong organizational and interpersonal skills with a customer service focus
76

Regulatory Operations Specialist Resume Examples & Samples

  • MS applications, which includes working with templates, and editing and formatting complex documents
  • Prior experience with electronic regulatory submissions and publishing software
  • Working knowledge of submission structures and the medical device development process and related document requirements
  • Advanced use of Adobe Acrobat or other Adobe plug-in publishing tools
  • Advanced knowledge level of MS applications, which includes creating templates, editing and formatting complex documents in Word, PowerPoint, Visio, Excel, and Access
77

Head of Global Regulatory Operations Resume Examples & Samples

  • Direct and develop the Global Regulatory Operations team to efficiently deliver on all operational priorities in all regions: EU, USCAN, LatAm, EAGM, APAC
  • Prioritize and balance operational workload to secure the best outcomes, take decisions to resolve complex issues, use experience and judgment to achieve all operational deadlines
  • Oversee all business-critical submissions, strategies and plans, providing functional expertise to cross functional teams
  • Be the subject matter expert for Health Authority requirements and for regulatory information systems: document management, submission publishing, registration tracking, submission planning, submission archiving, IDMP
  • Drive process improvements, deliver new external mandatory requirements (eg. xEVMPD, IDMP) and new internal business initiatives (eg. simplification)
  • Direct outsource partners to execute on all work activities, to fulfill project objectives and to meet all Key Performance Indicators
  • Oversee the development of processes, policies, guidelines, SOPs and Training Manuals
  • Build Relationships with Industry Working Groups and Agencies to ensure future global, regional or national mandatory requirements are known and fulfilled
  • Bachelor’s degree in a relevant scientific or Life Sciences discipline and/or significant experience in a Global Regulatory Operations leadership role or equivalent knowledge and experience
  • Strong track record of Pharmaceutical / Life Sciences experience managing operationally focused activities or teams within Regulatory Affairs
  • Ability to multitask effectively in a fast-paced environment with often shifting priorities
  • Ability to work independently with minimal supervision or direction
  • Line Management Experience, excellent communicator and team leader
  • Resourceful attitude and proficient at making the necessary decisions to achieve business objectives
78

Regulatory Operations Associate Resume Examples & Samples

  • Advance those of the Regulatory Operations Associate I to include the following
  • Provides input into scheduling and planning of submission timing in collaboration with Regulatory Affairs
  • Builds and maintains correspondence and commitments related to their assigned programs
  • Assists with system implementation and upgrade activities
  • Participates in the development, refinement, and rollout of internal guidelines, procedures, and processes pertaining to submissions and records management
  • Demonstrates awareness of Regulatory Agency rules and guidelines pertaining to regulatory (electronic) submissions
  • Supports or leads Regulatory Operations initiatives, as assigned
  • B.A./B.S (or equivalent work experience)
  • 1-3 years of experience working in pharma/biotech with direct experience in regulatory submissions
  • Demonstrates technical proficiency and expertise in MS Office tools, Adobe Acrobat, and applications for electronic document management and/or electronic report publishing (e.g. Documentum, ISI ToolBox, Core Dossier and ARIM)
  • Demonstrates an emerging understanding of the applicable regulatory requirements and regulations
  • Demonstrates ability to handle stressful situations and stay focused in difficult situations
  • Ability to handle multiple tasks at the same time and meet internal timelines
  • Demonstrated ability to interact with team members and health authorities
79

Manager Regulatory Operations Resume Examples & Samples

  • Technology: Manages all dossier publishing programs and/or project planning applications. Supervises the identification, compilation, and assembly of required documentation for various regulatory submissions. Advanced, tactical working knowledge of the changing Health Authority guidelines regarding submissions. Provides input on regulatory submission process improvements and the establishment of repeatable processes utilizing key technologies
  • Process: Manages the evaluation of processes to ensure organizational responsibilities are met with the highest degree of quality and timeliness. Coordinates and oversees the dossier assembly/production process and structural organization of regulatory dossiers. Identifies, plans, and manages general business process improvement opportunities. Leads/drives in the development of business processes with internal and external partners
  • People: Establishes and maintains effective timely communication across Regulatory Operations including Regulatory Affairs. Works with and represents RA’s needs as appropriate. Manages Submission tactical activities and/or dossier team meetings. Communicates and actively collaborates with managers and leaders concerning the dossier process; assists in creating, communicating, and implementing organizational goals and objectives. Trains personnel in regulatory submission, review, and publishing, and planning activities ensuring compliance. In collaboration with leadership may help to conduct departmental meetings
  • Submission Team Leadership/Group Facilitation: Demonstrates an expert understanding of dossier team process and role of each contributing discipline. Attends and leads (when appropriate) the dossier team meetings. May oversee & maintain dossier planning issues log and begins assuming more responsibility with MS Project planning. Takes leadership role in facilitating Specialist initiatives/meetings. Regularly leads functional meetings with internal/external contributors
  • BA/BS in relevant discipline desired (or equivalent years' experience)
  • 5-7 years industry experience (preferably in Regulatory Operations/Regulatory Affairs or project management)
80

Regulatory Operations Operator Resume Examples & Samples

  • Close collaboration with GMO Teams in Germany, India and United States
  • Ensures appropriate escalation of operational, regulatory and other risks to the COO and functional Leadership functions; contributes to the development and implementation of solutions to monitor and mitigate risk
  • Validates, monitors & measures the efficiency and effectiveness of own end-to-end Operations processes on a regular basis and identifies improvement opportunities in the area of responsibility
  • Several years of experience in global banking or OFAC Regulatory Filtering appreciated
  • Knowledge about DB Systemlandcape preferable
  • Open minded, able to share information, transfer knowledge and expertise to team member
  • Bachelors Degree in Business Management/Finance/Banking/Economics or related discipline
81

Regulatory Operations Specialist Resume Examples & Samples

  • Compilation and publishing of regulatory submissions for assigned products/projects in accordance with health authority standards and processes
  • Collects necessary information from the project team, and plans submission related activities
  • Ensures regulatory submissions are compliant with health authority and customer submission standards
  • Manages the printing and distribution of regulatory submissions, paper and electronic, to all concerned markets
  • Supports the Regulatory Information team in the collection of regulatory status information
  • Supports and contributes to establishment of best practices
  • Develops self in topic areas critical to successful delivery of the submissions, particularly, technical skills (electronic submission standards), knowledge of regulatory submission regulations
82

Regulatory Operations Operator Resume Examples & Samples

  • Sending email to clients for collection of tax form
  • Sending of email for cases where we need to chase unresponsive clients
  • Sending of mails for cases for which incomplete documents are received and invalid tax documents received
  • Answering of Client Queries
  • Perform UAT testing in DBCAR system for new system releases
  • Validation of tax form in CTI tool
  • Graduates with good academic records
  • Good Email Etiquettes
  • Strong Excel is required (ability to independently perform vlookups, pivot tables, etc)
  • Working knowledge of DBCAR and CTI tool is preferred
  • Ability to work with complex sets of data
  • Ability to work effectively both as a team member and independently
  • Knowledge of different type of tax forms in US is preferred
  • *Willingness to work in shifts
83

Senior Regulatory Operations Spec Resume Examples & Samples

  • Competency with various software packages: (Word, PowerPoint, Visio, Excel, Access, Internet, HTML code)
  • Work within a variety of systems, Document Management System, UDI RA Portal, and Regulatory database for managing changes and submissions
  • Working knowledge and/or experience working in SAP or other related system
  • Experience with Documentum or other document management systems used in the medical device/pharmaceutical industry
  • Advanced knowledge level of Microsoft applications, which includes creating templates, editing and formatting complex documents in Word, PowerPoint, Visio, Excel, and Access
  • Experience with Internet/Intranet technology and interactive software applications
84

Coo-wealth Management Ops-regulatory Operations Operator Resume Examples & Samples

  • Conduct review all regulatory reporting requirements to ensure compliance with regulation in each jurisdictions
  • Ensure that all new regulations and changes to existing regulations are identified and properly assessed for their impact to the bank
  • Provide assurance that effective processes and controls are in place to manage and perform the Regulatory Reporting tasks
  • Work collaboratively with team members, regulatory leads within Business Units, other colleagues involved in regulatory policy and external contacts to drive policy conclusions and implementation and ensure consistency of regulatory policy approach
  • Liaising closely and working collaboratively with counterparts in other regions to ensure consistency and harmonization of approval on global issues
  • Escalate issues / red flags identified, which may result in late or incorrect regulatory submission to senior management for resolution and remediation
  • Participate in methodology reviews and implementation of any methodological changes
  • Participate in system enhancement IT and support process improvement projects
  • Minimum with 5 - 7 years operations experience with in a banking / financial sector, preferably familiar with the regulatory reporting
  • Good understanding of HKMA / MAS / SFC requirements
  • Good analytical skills, flexible regarding production problem solving
  • Ability to work in virtual teams and in a matrix organizations
  • Ability to work within tight deadlines and to prioritize
85

Regulatory Operations Manager Resume Examples & Samples

  • Manage day-to-day regulatory operations and workload of regulatory team, plan resource needs and strategize growth
  • Represent CRS Quality and Compliance as a regulatory consultant at process improvement workgroups, institutional meetings, and conferences
  • Provide regulatory support to NCI NCTN program and Institution-Sponsored IND (ISI) Program and oversee maintence of all required regulatory documents
  • Provide regulatory start-up support for the central Study Start-up Team including industry-sponsored and investigator-initiated trials
  • Partner with Consortium study teams to provide ad hoc regulatory management for ongoing clinical trials
  • Oversee, coordinate, and prepare regulatory study start-up documents and maintenance of protocol submissions to internal and external governing bodies. These include but are not limited to the Cancer Consortium IRB, NCI Central IRB, the Institutional Biosafety Committee, Radiation Safety Committee, and Scientific Review Committee
  • Oversees timely regulatory submissions to meet institutional, NCI NCTN and other relevant project timelines
  • Create and maintain Standard Operating Procedures (SOPs) and ensures program compliance with the SOPs
  • Identify program improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to Consortium study teams
  • Coordinates with Regulatory Affairs team as needed to address regulatory-related quality and compliance matters
  • Assists with the development of standard training requirements and assists with ongoing regulatory-related education and training for. investigators and research personnel Perform internal audits and quality assurance reviews on regulatory files, as needed
  • Write and edit clinical research trial consent forms in accordance with FDA regulations and guidances and GCP guidelines
  • Liaise with investigators, study teams, sponsors, and Institutional Review Office (IRO) representatives on all clinical trial regulatory operations
  • Experience coordinating clinical research, preferably oncology trials
  • Minimum of 5 years of regulatory experience in the conduct of interventional, treatment, and/or FDA regulated clinical trials, preferably oncology trials
  • Knowledge of NCI cooperative group clinical trials
  • Experience as a lead or senior coordinator; supervisory experience preferred
  • Master’s degree in a healthcare related field preferred
  • Clinical research related certification required
  • Knowledge of NCI cooperative group trial structure
  • Advanced knowledge of FDA regulations, GCP guidelines and other applicable federal regulations
  • Ability to work on multiple projects and delegate tasks effectively
  • Excellent interpersonal skills with the ability to build strong relationships across multiple organizations
  • Advanced knowledge of electronic IRB submission systems and/or clinical trial management systems (CTMS)
  • Advanced knowledge of standard office software packages (Word, Excel, PowerPoint, Project, Acrobat, Visio, etc.)
86

Lead Product Regulatory Operations Specialist Resume Examples & Samples

  • Apply knowledge of regulations, as well as health plan operations knowledge to operational compliance issues identified by CMS, OIG, NYS and other governmental oversight entities
  • Work successfully with business department staff to provide guidance and assist in the implementation of best practices related to these issues, and collect and manage data and reports as needed to assure management that EmblemHealth has corrected the issue and has sufficient oversight in place to ensure that issues will not recur
  • Implement process changes to bring the operation into full compliance with regulatory requirements pertaining to regulatory operations, provide data and reporting that will assist management in planning enhancements to the operational monitoring process, and work directly with business department (s) to ensure that processes are in place that minimize regulatory risk to the plan
  • 4 -6 years’ work experience in regulatory healthcare operations compliance required
  • Thorough knowledge of State and/or Federal programs operations and regulations required
  • Proficiency in the use of Microsoft Office (Word, Excel and Access) required
  • Proven ability to establish and maintain relationships of trust with departmental staff and management
  • Proven ability to coordinate and lead interdepartmental work teams and meet established goals
87

Director, Global Regulatory Operations Resume Examples & Samples

  • Serve as a subject matter expert on regulatory operations related issues by communicating proactively and effectively with the VP Global Regulatory Affairs and Quality Assurance
  • Ensure the Company is kept current with all new submission-related regulatory requirements and evolving electronic regulatory environment, and provide guidance to senior management on the implications of any new or updated requirements
  • Analyzes trends and evaluates the impact of changes in Regulatory Agency requirements for e-submissions; communicates changes to appropriate areas and implements required changes to submission filings to ensure compliance with required standards
  • Maintain a world-class regulatory operation system and standards including publishing and archiving
  • Interface regularly with Regulatory Leads to maintain an overview of upcoming submissions for all products and, when necessary, establish prioritization between the different products under the direction of the VP Global Regulatory Affairs and Quality Assurance
  • Accountable for the overall planning and management of Regulatory resources and budget to effectively support Global submissions (IND, NDA, CTA, MAA, drug listing and maintenance activities)
  • Responsible for managing the logistics, preparation, quality assurance, delivery and archiving of regulatory submissions in accordance with Regulatory Agency requirements, company standards, and timelines
  • Implement a submission process to support new product submissions, maintenance and renewals for company products
  • Develops and provides in-house training according to Regulatory and submission project team needs; this includes authoring templates, style guide formatting requirements, processes and tools critical to compiling all submission types. Participates in the writing and reviewing of Regulatory processes (SOPs, Work Instructions and internal guidelines). Oversees execution of departmental policies/procedures for product submissions
  • Monitors progress of submissions through registration approval process
  • Implement the use of authoring software/tools (templates) for contributors that are compatible with vendor Regulatory submission publishing system
  • Maintains effective relationships with external publishing vendors/contractors to help manage the Regulatory submission workload
  • Identify and allocate internal and external resources (vendors/CROs)
  • Hire, manage, support and develop/train Regulatory Operation staff and secure sufficient resources to support the company’s goals and objectives
  • Travel (domestic and international)
  • Maintains a performance and improvement culture
  • Minimum Bachelor’s Degree in a life science-related discipline
  • Advanced degree (PharmD or PhD) preferred
  • 20+ years of experience in the pharmaceutical/biotechnology industry
  • Minimum 7 years leadership/management of Regulatory Operations groups and demonstrated organizational/planning skills
  • Proven ability to interpret regulations, to define and communicate strategy/plan to teams across multiple programs
  • Highly knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for submission types (e.g. IND, MAA, CTA, DMF, NDA, PSUR, etc.)
  • Keeps current of regulatory submission publishing standards to ensure compliance with Regulatory Agency’s requirements
  • Experience in publishing and compilation of eCTD submissions for US filings is required and experience publishing ex-US electronic submissions is desirable
  • Strong knowledge of US and other major global (ICH, EU, Asian) regulatory requirements
  • Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools
  • Ability to build and manage relationships with business partners
  • Strong proven hands-on Regulatory Affairs/Operations experience and knowledge of pharmaceutical regulatory submission requirements for global filings (FDA and/or EMA, etc.) is required
  • Ability to multi-task in a very fast-paced environment, pay close attention to detail, and follow projects through to completion to meet deadlines
  • Ability to work independently as well as work in a team environment with changing timelines and priorities
  • Ability to manage changing departmental priorities, evaluate and assign resources, and communicate timeline and resource impacts to project teams and management is required
  • Experience with multiple aspects of the product development (CMC, nonclinical and clinical)
  • Must be able to effectively collaborate with peers and comfortable working in a matrixed team
  • Must be solutions oriented and pragmatic (with analytical thinking and problem solving skills)
  • Excellent project management and organization skills is a must
  • Excellent communication skills (verbal and written) and interpersonal skills
88

Submissions Specialist Global Regulatory Operations Resume Examples & Samples

  • Responsible for planning, compiling, tracking, dispatching, and archiving regulatory documents and submissions in both paper, eCTD, and other electronic format
  • Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including MAAs/NDAs, INDs, DSURs, PIPs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, Briefing Books, etc
  • Technical verification of regulated documents via workflows within electronic document management systems
  • Liaise with functional source areas (clinical, nonclinical, quality, regulatory) to ensure documents are compliant with authoring style guide. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications
  • Responsible for maintenance of all Regulatory and FDA correspondences (archiving into electronic document management system) within specified time frames
  • Adherence to required submission timelines, health authority publishing specifications, and internal working practices
  • Other responsibilities related to the above within Celgene as a whole, as assigned
  • Knowledge of IND, NDA, MAA, CTD requirements and guidelines; both paper and electronic required
  • Must have experience working in Electronic Document Management Systems (EDMS)
  • Experience publishing eCTD using electronic publishing system and tools
  • Knowledge of industry trends regarding electronic submissions
  • Proficiency with MS-Office Suite and Adobe Acrobat application
  • Ability to balance multiple tasks to meet priorities and timelines
  • Self-starter with superior time management skills, and ability to work independently and in teams
  • MONEU
89

Capital Markets Regulatory Operations Specialist Resume Examples & Samples

  • Motivated and experienced SQL and VBA developer
  • Effective time management skills with an ability to work in a dynamically changing environment with multiple deadlines
  • Demonstrated leadership abilities and teamwork skills as well as the ability to accomplish tasks under minimal direction and supervision
  • Knowledge of Derivatives, Foreign Exchange or Cash Securities is a plus
90

Regulatory Operations Operator Resume Examples & Samples

  • Ability to work productively and collectively with others
  • Experience with trade processing systems, including Broadridge-BPS
  • Attention to detail and ability to multi-task
  • Excel & PowerPoint skills
91

Regulatory Operations Supervisor Resume Examples & Samples

  • Monitor Associate Producer assignments and bandwidth, making changes and responding to new brand requests as needed
  • Attend weekly new business meetings and assign Associate Producers to new business projects
  • Liaise with new business coordinators to ensure pitch needs are being managed
  • Work with coordinators on pitches (developing skill set to be more engrossed in the overall pitch)
  • Manage DOLORES access, team challenges, training, and workflow efficiencies
  • Foster a positive team atmosphere and establish credibility both internally and externally
  • Liaise with Studio, IT, and Facilities
  • Demonstrates ability to set priorities while handling multiple projects
  • Set server structure hierarchy for existing/new clients
  • Perform other job-related tasks as assigned by his/her supervisor
  • Is a key person in assisting everyone in the company in identifying problems and helping the company be profitable
  • Keep senior management briefed on activities and developments within Agency Operations
  • Maintain and distribute welcome guide to new hires
  • Create and maintain team distribution lists
  • Rollout of new processes and technologies (e.g., DOLORES, WorkFront)
  • New hire training – all agency (inc DOLORES, WorkFront, server and coordinating departmental training sessions), new hire set-up (inc BT Conferencing Numbers and devices), seating, buddies, etc
  • Printing of internal documents (new business)
  • Open purchase orders (as a back-up)
  • Request non-billable numbers
  • Route pro-bono & non-billable jobs
  • Maintain and update PPT process decks as needed
  • Organize conference rooms for pitches
  • Initiate brand welcome signs
  • New hire set-up (inc BT Conferencing Numbers and devices), seating, buddies, etcSet up internal & client group emails
  • Maintain brand lists
  • Distribute Studio FTP list
  • Member of RAPS is a plus
  • Problem solves, diffuses heated situations and initiates practical solutions
  • Presents new initiatives to better utilize resources while eliminating inefficiencies
  • Embodies service-oriented attitude
  • Upholds quality standards in servicing the Client
  • Projects a professional, positive attitude and image, always representing the agency well
  • Anticipates what is needed before anyone else sees it
  • Stays calm under pressure and be a leader no matter what the issue
  • Well-developed knowledge of business practices/vendor relations
  • Ability to manage and train staff
  • Cross-platform (MAC & PC) knowledge
  • Ability to interact with others in a team setting
  • Provides leadership and guidance through mentoring others
  • Detail-orientated
  • Demonstrates ability to solve problems
  • 10+ years of experience
  • Hands-on experience with technology based initiative and solutions
  • Integrated experience essential; traditional and digital
  • Background in Pharmaceutical advertising is preferred
92

Operations Lead Regulatory Operations User Acceptance Testing Lead Resume Examples & Samples

  • Develop an in depth understanding of Regulatory Operations reporting suite
  • Work with Control team within RCP and Technology Partners to ensure full understanding of requirements, sufficient handover to the UAT Cycle and the successful execution of test cases for control reports and exception flows through dbexplore & dbExMan
  • Active engagement of Global RCP teams in Birmingham, Jacksonville, and Manila and Singapore ensuring each team understands testing requirements ahead of each UAT cycle
  • Management of UAT Cycle, setting up daily status calls, defect tracking, moving Jiras status to Ready for Release once UAT signed off
  • Effective communication with key stakeholders, ensuring management kept up to date with progress, challenges and required escalations
  • Provide training to Regulatory Operations team via conference calls, web ex and release documentation
  • Future planning around ownership of the development of UAT test packs for execution by Regulatory Operations team through creation of generic test scripts / scenarios which can be modified for each release cycle
  • Understanding of full architecture solution for MiFID II, creating and managing test plan to track and support all deliveries
  • Management of the UAT for control outputs for MiFID II
  • Very good attention to detail and a mind-set where you continually look to challenge (Essential)
  • Previous testing role experience (Essential)
  • Experience of working within projects (Essential)
  • Experience of working environments with flexible / changing timescales & priorities (Essential)
  • Previous business analyst / test manager experience (Beneficial)
  • Understanding of Regulatory Operations (Beneficial)
  • Product knowledge for asset classes supported by Operations (Equity, Fixed Income, Derivatives, Rates, Listed Derivatives) (Beneficial)
  • Knowledge of Excel, Visio & PowerPoint, Jira (Beneficial)
93

Regulatory Operations Publishing Associate Resume Examples & Samples

  • Project Document Processing including
  • Master’s degree in natural science, life sciences or pharmacy
  • Knowledge of eCTD including eCTD software
  • Proficiency in submission publishing for other submission formats (such as NeeS or paper)
  • Proficiency in the use of publishing tools to generate required formats
  • Proficiency in the use of Adobe Acrobat tools to generate submission ready content
  • Excellent written and verbal communication skills in English
  • Establishes excellent working relationships with peers and team members through integrity, credibility, reliability and trust
  • Ability to work on numerous projects and under pressure
94

Senior Associate, Regulatory Operations Resume Examples & Samples

  • Represent Regulatory Operations by participating on assigned teams to support submission scheduling and ensure coordination of system development activities
  • Provide detailed project timeline information to supervisor to support resource forecasting
  • Coordinate and participate in the production of electronic regulatory submissions and, as required, paper submissions
  • Develop proposals for system and process development or modification to support greater efficiency and continued regulatory compliance
  • Assist with the development and implementation of processes related to submission standards, working practices, and quality controls
  • Support and conduct cross functional training on submission standards and procedures as required
  • Support compliance with worldwide submission regulations and guidelines
95

Senior Associate Regulatory Operations Publishing Resume Examples & Samples

  • Attend seminars and courses to maintain career growth and to stay updated on changes to Agency guidance
  • Other duties as assigned with or without accommodation
  • 5+ years experience with electronic submission software and/or other related industry specific software
96

Capital Markets Regulatory Operations Analyst Resume Examples & Samples

  • Bachelor degree required
  • Self-starter with detailed analytical and data management skills
  • Demonstrated leadership and teamwork skills as well as the ability to accomplish tasks under minimal direction and supervision
  • Excellent communication skills, ability to concisely present data to senior management
  • Understanding of Operational processes and systems
  • Process development experience with a keen eye for automation and enhancing controls is a plus
  • Knowledge of Derivatives, Foreign Exchange, Cash Securities or financial regulatory requirements is a plus
97

Senior Regulatory Operations Analyst Resume Examples & Samples

  • Compiles, reviews and submits regulatory reports (e.g., TIC, LOPR, Short-Interest, EBS, INSITE) for the firm to various regulatory agencies (e.g., Federal Reserve Bank, FINRA, SEC)
  • Researches and analyzes reporting variances, data quality issues and exceptions
  • Interprets new/changing rules, reporting requirements, regulations, policies or laws
  • Responds to external/internal inquiries and ad hoc requests relating to previously filed reports
  • Plans and executes all aspects of remediation efforts for any identified issues with minimal guidance from Manager
  • Formalizes the milestones needed in order to implement corrective action plans for any identified issues; owns and drives the action plan for any opportunities/gaps identified
  • Participates in various data quality projects to implement/enhance the data warehouse, analyze regulatory reporting system logic and perform UAT testing
  • Brokerage operations, financial markets, financial products and services, industry rules and regulatory reports (e.g, TIC, Electronic Blue Sheet, Short-Interest, Large Option Position Report, INSITE)
  • Microsoft Excel and database systems
  • Concepts, practices or procedures for testing operational systems/processes
  • Conducting quality controls reviews
  • Evaluating processes/systems and identifying risks and controls
  • Recommending appropriate actions/revisions to resolve any identified gaps or mitigate risk
  • Designing and implementing training materials and programs for his/her team
  • Microsoft Office applications (Excel, Access, PowerPoint) and other software
  • Designing, developing and executing test strategies, methodologies and analysis
  • Research, compile, and perform complex analysis on critical operational data
  • Manage multiple tasks with changing priorities; meet deadlines in a fast paced environment with constant interruptions
  • O Ability to quickly understand complex subject matter and demonstrate critical thinking
  • Bachelor’s Degree (B.A.) in related field and a minimum of three (6) to five (8) years’ experience in the areas of accounting, banking and/or financial services
98

Regulatory Operations Coordinator Resume Examples & Samples

  • Prepare quality regulatory submissions that are complete, timely, accurate, and well-written under the supervision of State Regulatory Operations team members. These may include institutional renewal, new program, initial and renewal agent licensing, and substantive change applications and notifications
  • Assist with state research and analysis on relevant topics and issues
  • Develop and maintain strong relationships with internal stakeholders and assist State Regulatory Operations team with maintaining strong relationships with state agencies
  • Maintain paper and electronic regulatory filings for short and long term storage and access
  • Support State Regulatory Operations efforts by coordinating fee payments, bond renewals, signature requests and other general administrative support as needed
  • Excellent written and verbal communication skills, including editing and proofreading
  • Experience working with external regulatory agencies and stakeholders, and/or in the higher education industry
99

Regulatory Operations Specialist Resume Examples & Samples

  • ERP System:-
  • A minimum of two years’ experience in regulatory role in a medical device company
  • Post graduate experience working in corporate environment preferably health related industry
  • Computer literacy including sound knowledge of the MS Office suite of software
  • Ability to build strong customer (internal and external) relationships throughout the organization, at all levels
  • Bachelor’s degree in Science /related field or equivalent would be preferred but is not essential
  • Excellent communication and interpersonal skills. Strong negotiation / resolution skills
  • Ability to work independently and also actively participate as a team member
  • Self motivated and positive
  • Outgoing and friendly, willing to assist others
  • “can do” attitude
  • Ability to accomplish numerous tasks simultaneously
  • Demonstrated project management skills
  • Strict attention to details
  • Conscientious
  • Patient and persistent
  • Model Medtronic Leadership Expectations & Behaviours
100

Regulatory Operations Specialist Resume Examples & Samples

  • Minimum of 2 years at a medical device or pharmaceutical company
  • Regulatory Affairs Certification (RAC), Regulatory Science B.A. or M.S
  • Experience with Global Trade Services and SAP
  • Working knowledge of submission structures, the medical device development process, and related document requirements
  • Experience implementing systems in large, de-centralized organizations
  • Advanced IT knowledge and experience with Microsoft applications
101

Regulatory Operations Specialist Resume Examples & Samples

  • 2+ years’ experience
  • Bachelor’s Degree in life sciences or technical field
  • Functional knowledge of US and key international regulations
  • Knowledge of Quality System standards and regulations (21CFR sections 820, 210/211, ISO13485, Medical Device Directive) and how they relate to the job duties
  • Experience with FDA requirements, ISO 13485 and Medical Device Directive or other regulatory requirements
  • Superior interpersonal, written communications, time management, and organizational skills
  • Demonstrated advanced software skills, including Microsoft Word, Excel, PowerPoint; Adobe Acrobat; and database skills
  • Ability to prioritize, conduct team meetings, and meet project deadlines
  • Experience working with technical documentation
  • Must be able to handle multiple tasks/projects and manage priorities accordingly
  • Experience or coursework in regulation of medical devices or experience working with medical devices
  • Project management skills and experience
  • The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
  • While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer, and communicate with peers and co-workers
  • Specific vision abilities required by this job include the ability to adjust focus
102

Senior Manager, Regulatory Operations Resume Examples & Samples

  • Oversee project submission timelines, schedules and regulatory submission processes
  • Lead compliant submissions for FDA and Health Canada, along with other international agencies including advanced paper publishing and working with 3rd party resource for electronic publishing
  • Perform quality assurance of submission documents and published output including formatting, navigation and dataset completeness
  • Administer document management tasks including file transfer, off-site storage, tracking and correspondence archival
  • Assist in identifying and implementing new technology platforms, including content management and publishing systems
  • Support operations submissions publishing and archiving
  • Oversee development and implementation of processes related to submission standards, working practices and quality controls
  • Maintain familiarity with current and future global regulatory submission standards
  • Bachelor’s degree or equivalent in life sciences or technology-related discipline
  • 8-10 years regulatory affairs operations experience, or commensurate experience in relevant areas
  • Preferred regulatory publishing experience managing clinical documentation
  • Knowledge of U.S. and international regulations including cGMP, GCP, GLP, ICH guidance documents
  • Knowledge and understanding of global regulatory submission formats, industry standards, and guidelines, validation concepts, and publishing best practices including eCTD format and registration tracking
  • Ability to work with high level contacts and exposure to sensitive information necessitating considerable use of tact, diplomacy, discretion and judgment
  • Experience with effective project team participation and management oversight
  • Professional, proactive demeanor
  • Intellectual Horsepower
  • Integrity and Trust
  • Composure
  • Standing Alone
103

Regulatory Operations Operational Risk Team-risk Management Associate Resume Examples & Samples

  • Partner with CB Senior Managers, Compliance and others in the execution of our annual Risk and Control Self-Assessment program
  • Evaluate the quantity and quality of inherent risk against established tolerance levels, monitor outcomes/ risk levels for operational areas
  • Review existing processes and procedures for efficiency and effectiveness and assist in implementing improvements when required
  • Verify that policies, procedures and business requirement documentation are sufficient, current and reflect proper control design
  • Conduct process observations and self-audits, test key controls and review control reports to ensure operational compliance and proactively identify gaps
  • As new processes are developed, ensure proper controls and procedures are in place to mitigate risk and that the framework is updated for ongoing testing
  • Track progress on Action Plans to ensure they are completed timely and accurately - escalate to senior management when needed
  • Validate adequate completion of Action Plans prior to closure
  • Update process maps as changes occur in the department processes and procedures
  • Provide management reporting on RCSA/Testing reporting metrics, milestones and deliverables
  • Partner with the business analytics team to periodically generate ad hoc reports for management
104

Director, Regulatory Operations Resume Examples & Samples

  • Oversee global publishing and submission process for domestic and international regulatory bodies
  • Manage the process from inception to approval
  • Utilize systems and tools for electronic document capture, generation, manipulation, scanning and QC
  • Coordinate and supervise development/implementation of technology and processes to manage timely and effective publishing and document management, meeting emerging global requirements
  • Oversee maintenance of all technologies and infrastructure needed to facilitate transactions with Sponsors, within Medpace departments, and with regulatory agencies globally
  • Coordinate validation of all electronic Regulatory operations systems (Part 11 compliance); and
  • Oversee compliant archiving of all regulatory documents with permissions in place for access
  • Advanced degree in a related field
  • At least 8 years of global drug development and regulatory operations/affairs experience in the CRO, Biotechnology or Pharmaceutical industries
  • Proven leadership and program management experience
  • Creative thinker, motivational leader, strong manager
  • Strong team member and collaborative team player
  • Strong computer skills, project management skills, and a high attention to detail
  • Strong communication skills (both written and oral); and
  • Passionate about growing a strong and productive global regulatory operations organization
105

Regulatory Operations Operator Resume Examples & Samples

  • To contribute to projects within the department and be responsible for the in-scope population assigned whilst developing an understanding of the process and regulatory requirements. At times may be requested to take the lead on a project
  • Create weekly Management Information (MI) on project status and be able to deliver clear, concise and accurate daily updates to local and functional Stakeholders
  • Highlight inefficient processes, look for and implement improvements within local team
  • Interact and work with internal and external counterparties
  • Identify and escalate issues to Project Leaders
  • Ability to learn and understand various regulatory requirements to provide effective client support
  • Understanding of Client On-Boarding process and systems
  • Ownership and tracking of items to resolution
  • Understanding of and ability to deliver concise and clear Management Information (MI)
  • Effective Multi-tasker with a proven track record of dealing with multiple processes simultaneously
  • Very proficient with Microsoft Office – especially intermediate and above Excel skills - experience with data analysis, pivot tables, vlookups is beneficial
  • Understanding of Sales & trading environment would be beneficial
106

Regulatory Operations Operator Resume Examples & Samples

  • Understanding of and ability to deliver concise and clear MI
  • Effective multi-tasker with a proven track record of dealing with multiple processes simultaneously
  • Confidence working with senior executives and directors
107

Regulatory Operations Operator Know Your Client Remediation Outreach Resume Examples & Samples

  • To be responsible for gathering business and client information required to complete the necessary due diligence for Deutsche Bank clients
  • To act as an intermediary between the Know Your Client (KYC) Compliance Analyst conducting the due diligence and the Front Office and their clients
  • To communicate clearly and build a rapport with Front Office contacts and clients in order to source and retrieve the required information as efficiently as possible
  • Ensuring documentation/reporting is maintained and complete in all areas such as checking that the documentation retrieved in the first instance matches the requirements provided by the KYC compliance analyst
  • Ensure all required KYC documentation is received, validated and escalated accordingly
  • To contribute to projects within the department and be responsible for the in-scope population assigned whilst developing an understanding of the process and regulatory requirements. At times might be requested to take the lead on a project
  • Create weekly MI on project status and be able to deliver clear, concise and accurate daily updates to local and functional Stakeholders
  • Highlight inefficient processes, look for and implement improvements within local team
  • Work with internal and external counterparties
  • Identify and escalate issues to Project Leaders
  • Experience with data analysis, pivot tables, vlookups is beneficial
  • Ownership and tracking of items to resolution
  • Delivery against set timelines and objectives
  • Understanding of and ability to deliver concise and clear Management Information (MI)
  • Flexible and adaptable to change given the nature of the role and potential priority changes
  • Effective problem solving and mediation skills
  • Excellent communication skills – both written and verbal
  • Very proficient with Microsoft Office – especially intermediate and above Excel skills - experience with data analysis, pivot tables, vlookups is beneficial
  • Fluent English essential. Any other language skills are beneficial
108

Regulatory Operations Manager Resume Examples & Samples

  • Oversee all activities conducted by the EU Regulatory Operations Team and acts as an escalation point for all team members - responsible as the team leader for being a role model to the global publishing teams
  • Regular communication with the client, including face-to-face meetings, presentations, telephone, email, and conference calls
  • Perform submission QC, resulting in a high quality final product
  • Conduct issue resolution, communicating with the client and their functional areas to ensure that all issues are resolved in a compliant manner
  • Provide internal training, mentoring and supervisory support to Regulatory Operations staff as well as project-specific training to internal staff and ongoing direction/guidance to all publishing team members throughout the project duration
  • Develop milestones and timelines, relay these objectives to the team, and ensure that the team is successful in reaching these goals
  • Ensure that the team follows, and strictly adheres to, internal standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the duration of the project, as well as project-specific specifications
  • Act as the primary liaison between third-party vendors and Accenture to ensure all submission project expectations are met in a timely manner
  • Manage resources, workload and budget for global publishing projects involving the EU RO Team
  • Manage relationships and coordinate work between different teams in different locations ensuring that internal and external project resources with appropriate skill sets are utilized
  • Monitor and report on execution of regulatory operations activities – monitor and report on deliverables and resource and workload management through all program/project phases
  • Assist/lead departmental committees and initiatives in the definition and continued development of standards and processes
  • Maintain global intelligence of product/project related HA regulations, submission guidance, recent approvals and precedents for clients’ therapeutic area and/or assigned projects
  • Provide specialist support of Business Development Activities as well as participate in meetings with potential clients in the proposal and delivery stages of customer engagement
  • Monitor existing services and Accenture capabilities to identify opportunities which provide additional and innovative value to the client
  • Create and deliver presentations, internally and externally (to clients/industry)
  • Provide strategic input into global regulatory operations plans for client, considering the full breadth of Accenture capability and taking into account Health Authority (HA) regulations and guidelines, and issues or topics directly related to the project
  • Responsible for development and management of direct reports, and pro-active supervision
  • Ability to lead multidisciplinary project team across multiple geographic locations to build collaborative relationships with client, health authorities and other experts in the Regulatory field
  • Proven project management skills, ability to work on numerous simultaneous projects, and proactively fulfil commitments to the client and Accenture
  • Experience of or exposure to sales process and management of financials
  • Ability to anticipate and address stakeholder needs in problem solving and risk mitigation
  • Ability to establish excellent long-term working relationships with clients, peers and team members through passion, integrity, credibility, reliability and trust
  • Established reputation as a regulatory operations subject matter expert across strategic as well as delivery and technical aspects of Regulatory Operations
  • Proven Regulatory generalist with a good knowledge of drug development and knowledge of non-EU/US markets
  • Outstanding communication (written and oral) and interpersonal skills as a key contact for clients and publishing team
  • Promotes the professional/personal growth of self and others to achieve individual and organizational goals
  • Self-motivated individual with initiative and an ability to work in a fast paced, high volume environment
  • Experienced Team Leader or People Manager, skilled in managing employees
  • Attention to detail and quality orientation
  • People-oriented with a mindset for both customer service and personal development
  • Assembly of CTD and Ectd
  • Expert knowledge of eCTD including eCTD viewer
  • In depth understanding of global regulations and submission requirements necessary for eCTD compilation, validation, submission and approval
  • Expert in eCTD lifecycle maintenance, proactively providing best strategy for all types of regulatory submissions (including, not limited to annual reports, variations, and supplements)
  • Author regulatory documents
  • Demonstrate proficiency in performing eCTD submission build (for example, leaf structure and backbone) or QC NeeS or paper submission output
  • Answer regulatory questions from client
  • Use industry-standard publishing and familiarity with regulatory information management tools
  • Interpret and apply ICH, US and European guidance to projects
  • Provide strategic regulatory operations guidance to clients
  • Use regulatory knowledge to propose new initiatives
  • Provide regulatory operations training both internally and externally (clients)
  • BD Activities: RFI, RFP, workshops and bid defences
  • Provide and defend Regulatory Operations solutions for Tier 1 clients
  • Strong and positive team leadership
  • Resolve performance issues with delivery leadership
  • Implement levers to consistently achieve performance targets
  • Fosters innovation and continuous improvement
  • Bachelor’s degree in natural science, life sciences or pharmacy; advanced degree is preferred. Minimum 6 years’ experience in a Life Sciences industry with a minimum 5 years of experience in pharmaceutical regulatory operations
  • Minimum 2 years’ experience in Project Management
  • Broad domain knowledge - knowledge of handling registrations and maintenance of pharmaceutical, medical device, consumer and/or cosmetic products from a global, regional and local perspective
  • Excellent international regulatory understanding and experience in handling business process excellence
  • Experience with publishing software and tools used throughout the Pharmaceutical industry
  • Experience in coordination and publishing of regulatory submissions for Investigational (IND, CTA) or Marketing Applications (e.g. NDA, MAA, NDS, MAA) to Global Health Authorities in eCTD, NeeS, or paper formats
  • A working knowledge of Pharmaceutical Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines (FDA, EMA, etc.)
  • Ability to travel and deploy without extended notice
109

Regulatory Operations Analyst Resume Examples & Samples

  • Supporting the team in triaging and resolving business process questions within the context of deployed applications; closely collaborating with project team members, business SMEs and IT partners to identify and deliver solutions
  • Providing business support for globally deployed applications, including support for identifying appropriate training, gaining access to applications and obtaining access to appropriate application components in support of the global user community
  • Helping to make sure that the team is providing business support within established Service Level Agreements; and helping track business support metrics
  • Supporting Regulatory Affairs in the gathering and reporting of business process metrics that will be used by leadership in order to help them identify and implement continuous improvement initiatives that can positively impact future business process metrics
  • Analysing trends in business support metrics and questions and helps implement long-term change management strategies to support application super users/local experts
  • Collaborating with project team members to gain deep understanding of existing, new, and revised processes and supporting technologies. Utilizes this understanding to provide and improve business support capabilities
  • Understanding existing and upcoming process and technology initiatives to effectively scale and enhance existing business support capabilities
  • Maintaining elements of the RA Business Support hub, including collaborating with specialized SharePoint SMEs as necessary
  • Degree level or equivalent in a business, IT or technology based discipline ideally
  • Ideally further IT qualifications e.g. ITIL or SharePoint
  • Proven strong MS Office skills including SharePoint, Excel and PowerPoint
  • Excellent communication skills - ideally experience within a multi-cultural setting
  • Experience of working in an international, matrix environment
  • Able to work with and manipulate detailed data sets
  • Experience of, or at least an understanding of, key performance indicators and / or reporting best practices
  • Experience with Regulatory Affairs systems is an advantage but not a must
110

Senior Associate, Regulatory Operations Resume Examples & Samples

  • This position’s primary focus is the formatting, publishing (including QC), transmitting and archiving regulatory submissions in both paper and electronic media to health authorities in the US, EU, CA and Rest of World
  • This position an advanced understanding of regulations and guidances associated with submissions
  • This position requires participate in sub-team meetings, volunteering for action items and participating in issue resolution
  • This position must able to answer most technical questions for many submission types. Must be able to troubleshoot and resolve some issues with critical computer application systems, e.g., MS Word and InSight Publisher
  • At least 3 years of experience in Regulatory Operations OR at least 2 years of related experience in Regulatory Operations and InSight Publisher certification
  • Must be proficient in MS Office 2013 (with an emphasis on MS Word) and Adobe Acrobat (version XI Pro preferred). Knowledge of eDMS and eCTD Publishing Systems (Livelink and InSight Publisher preferred)
  • Must have experience with electronic submissions, specifically eCTD. Work with functional areas to coordinate filings and have the knowledge and experience to publish more complex submissions
  • May determine methods and procedures on new assignments
111

Regulatory Operations Officer Resume Examples & Samples

  • Train on a set of processes to review and decision the validity of IRS Forms W-8 and W-9 received from customers, along with related certification documents
  • As the central processing unit for certain tax-related functions, learn proper update of codes and effective dates on customer accounts, as well as applying backup withholding rebates
  • Perform IRS TIN Match function, when required, in conjunction with form processing
  • Generate customer correspondence related to W-8 expiration or following receipt of invalid forms
  • Provide oversight to two GSC performing offshored functions related to this process, by supporting quality reviews and responding to inquires received
  • Service inbound calls/emails from RBWM customers who received correspondence generated by our team
  • Review reports that identify evidence on customer accounts that may indicate a change to U.S. residency status and generate applicable correspondence
  • Process B and C Notices received from the Internal Revenue Service by required deadlines, and perform related backup withholding transactions on customer accounts
  • Provide support to the process, and to the Sr. Regulatory Operations Officer, by identifying requirements, and participating in project deliverables including testing
  • Ensure all IRS deadlines are met to issue customer year end forms, i.e. Form 1098, 1099, 1042-S
  • Submit all IRS files by required deadlines containing customer data
  • Proven and progressive branch and/or operational experience
  • Developed organizational, communications, analytical, decision-making and customer service skills
  • Ability to handle multiple tasks in a fast- paced environment
112

Senior Manager Regulatory Operations & Controls Resume Examples & Samples

  • Excellent problem solving, critical thinking and negotiating skills
  • Excellent written and verbal skills to prepared documentation and ability to interact effectively with other bank departments and external parties
  • Strong leadership and time management skills
  • Thorough knowledge of regulatory compliance
  • Thorough knowledge of the roles and responsibilities of other bank service and support functions crossing all delivery channels
  • Thorough knowledge of project management and tracking techniques
  • Expert knowledge of Excel, PowerPoint, Word, MS Project, Business Objects and Visio
  • Highly motivated; fast learner, demonstrated ability to work under pressure and drive for results