Regulatory Affairs Coordinator Resume Samples

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GH
G Howe
Glen
Howe
91617 Donnelly Street
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+1 (555) 955 6885
91617 Donnelly Street
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Phone
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Experience Experience
Dallas, TX
Regulatory Affairs Coordinator
Dallas, TX
Goyette and Sons
Dallas, TX
Regulatory Affairs Coordinator
  • Tracking and facilitating the progress of new trials through the review process
  • Writing plain language informed consent documents
  • Working knowledge of clinical trial strategy and study design, statistical methods and data reporting
  • Offer assistance to support staff when new programs are instituted by the Company
  • May communicate with regulatory agencies or other consultants to coordinate the distribution and implementation of any new forms, SOPs, or current industry information to internal/external customers
  • Coordinates the on-boarding and documentation of new research staff within the USO network. Assists Transitions and Disaffiliation internal team to deactivate profiles, mail and file documents. 40%
  • Maintains close working relationship with R&D, Medical, Supply, Legal and Marketing staff to support team structure and is responsibility for influencing growth and development of the brands within the therapeutic area
San Francisco, CA
UK Regulatory Affairs Coordinator
San Francisco, CA
Lind, Mann and Walker
San Francisco, CA
UK Regulatory Affairs Coordinator
  • Brief CS interviewees ahead of regulatory meetings. Provide overviews of regulatory themes and issues and prepare staff for regulatory dealings
  • Tri-angulate with regulatory counterparts in US, APAC & EMEA/Switzerland to share knowledge and global regulatory strategies
  • Run the ongoing BAU relationship with PRA and FCA, responsible for administration, providing pre-data and reports, hosting meetings, distributing and tracking to completion any follow on actions
  • Prepare regulatory overview documentation for governance bodies and audit committees
  • Act as primary contact point between the Firm and the PRA / FCA and support coverage of relationships with regulators in other key EMEA locations
  • Uphold standards expected by CS in all regulatory dealings. Ensure that all regulatory meetings are accurately captured, and correctly administered
  • Manage Continuous Assessment supervisory process. Assemble and lead internal project board to gather potential issues, construct briefing manual, conduct briefings to staff (mass & individual), host all regulatory interviews, distribute themes and issues throughout regulatory visit, distribute findings, identify themes and ensure that regulatory sentiment is fully understood
present
Boston, MA
Dach Regulatory Affairs Coordinator
Boston, MA
Franecki-Wolf
present
Boston, MA
Dach Regulatory Affairs Coordinator
present
  • Create working instructions for IT business support applications and train them accordingly (COUPA, PEGA, SAP, etc.)
  • Order management of office and IT related equipment
  • Structure and control of new meaningful regulatory IT infrastructure and Share Point folder lists to allow efficient team integration work
  • Provide translations for review of AdProm Material
  • Support travel planning and expense management for DACH RA team and Head of EU LOC RA
  • Provide product related regulatory translations (German – English or vice versa) including agency communication, decisions
  • Proof reading of translated SmPC and PIL and related product labelling (artwork) according to regulatory standards (QRD template)
Education Education
Bachelor’s Degree in Science Required
Bachelor’s Degree in Science Required
California State University, Northridge
Bachelor’s Degree in Science Required
Skills Skills
  • Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, and follow-up of submissions under review
  • Strong knowledge and understanding of Microsoft Office
  • Ability to Research and analyze applicable regulations
  • Demonstrated skills in areas of communication, performance management, research and interpretation of regulations, and managing complex projects through matrix relationships
  • Good organizational skills, time management and follow up skills able to prioritize and handle several tasks simultaneously
  • Good command of the English language, in both written and verbal form. Proficient in Windows, as well as MS Word, Excel, PowerPoint
  • Excellent organizational skills and attention to detail
  • Knowledge of GCP, FDA, and other applicable regulations governing the conduct of clinical trials
  • Ability to work in fast paced environment and handle multiple tasks
  • Proficient in MS Office Word, Outlook and Excel
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15 Regulatory Affairs Coordinator resume templates

1

UK Regulatory Affairs Coordinator Resume Examples & Samples

  • Act as primary contact point between the Firm and the PRA / FCA and support coverage of relationships with regulators in other key EMEA locations
  • Manage Continuous Assessment supervisory process. Assemble and lead internal project board to gather potential issues, construct briefing manual, conduct briefings to staff (mass & individual), host all regulatory interviews, distribute themes and issues throughout regulatory visit, distribute findings, identify themes and ensure that regulatory sentiment is fully understood
  • Run the regulatory deliverables tracker, responsible for ensuring that the various regulatory initiatives are known and understood by the various stakeholders within CS. Project managing these initiatives, tracking to completion and timely escalation of potential issues
  • Run the ongoing BAU relationship with PRA and FCA, responsible for administration, providing pre-data and reports, hosting meetings, distributing and tracking to completion any follow on actions
  • Ensure that all regulatory requests are fully understood by the relevant stakeholders, organise regulatory requests into tangible deliverables, track to completion and timely escalation of potential issues
  • Co-ordinate the Firm’s response to formal regulatory “Dear CEO” letters. Organise regulatory requests into tangible deliverables, track to completion and timely escalation of potential issues
  • Uphold standards expected by CS in all regulatory dealings. Ensure that all regulatory meetings are accurately captured, and correctly administered
  • Brief CS interviewees ahead of regulatory meetings. Provide overviews of regulatory themes and issues and prepare staff for regulatory dealings
  • Tri-angulate with regulatory counterparts in US, APAC & EMEA/Switzerland to share knowledge and global regulatory strategies
  • Prepare regulatory overview documentation for governance bodies and audit committees
  • Co-ordinate regulatory reporting suite. Collaborate with stakeholders to ensure that accurate and appropriate information is provided in response to regulatory requests for information
  • Investment banking experience in control/risk functions
  • Experience of presenting to senior management
  • Experience having worked in a high pressure environment
  • Solid analysis skills and is intellectually inquisitive
  • Manage to learn and prepared to review detail
  • Operational Risk / Internal Audit / Regulatory background and/or experience
  • Confidence and ability to be self-starter
  • Understanding of sales and trading floor dynamics
  • Solid work ethic
  • Interest in learning Controls Framework
  • Knowledge of UK regulatory environment
  • Solid Microsoft (Excel/PowerPoint) skills
  • SharePoint experience preferable
  • MICOS experience preferable
  • Firm infrastructure experience helpful
2

Regulatory Affairs Coordinator Resume Examples & Samples

  • A Bachelor’s degree or related discipline or previous work experience in Regulatory Affairs that is equal to a 4-year degree is required
  • A minimum of 2-3 years of previous work experience in banking, lending, audit or compliance-related environment is required. Prior regulatory or government work experience and knowledge of banking and lending is preferred
  • Must be able to demonstrate proficiency with the following skills
3

Regulatory Affairs Coordinator Resume Examples & Samples

  • Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, and follow-up of submissions under review
  • Coordinates the planning, preparation, data collection, assembly, review and publication of regulatory submissions to the FDA and other government agencies
  • Reports and responds to agencies inquiries or comments
  • Assists with and prepares for FDA meetings, inspections, and audits from regulatory agencies
  • Prepares regulatory reports and coordinate data collection and reporting with other departments
  • Tracks changes in regulatory guidelines as they may occur
  • Prepares updates on laws, regulations and guidelines for distribution to appropriate study personnel and investigators
  • Maintains working knowledge of regulatory changes through guidelines, articles, writings and courses
  • Supports PI.s and study staff by assisting in the data collection and notification required for reporting of Adverse Events
  • Facilitates communication with IRB related to Adverse Events
  • Supports study monitoring, as needed and requested
  • Assists with regulatory affairs training
  • Time management and organizational skills
  • Knowledge of GCP, FDA, and other applicable regulations governing the conduct of clinical trials
  • Working knowledge of clinical trial strategy and study design, statistical methods and data reporting
  • Familiarity with medical and/or scientific terminology Proficient in use of MS Office software packages, spreadsheet analysis, database analysis
4

Regulatory Affairs Coordinator Resume Examples & Samples

  • Bachelor’s Degree in any field from an accredited college or university
  • One (1) year of clinical and/or research experience
  • One (1) or more years of regulatory experience
  • Experience working with NCI, Industry and Investigator initiated clinical trials
  • Experience working in an academic and/or medical environment
  • Experience working with University of Colorado Systems
  • Basic understanding of research specific to Human Subject Research protection, Good Clinical Practice, and IRB requirements
  • Good command of the English language, in both written and verbal form
  • Proficient in Windows, as well as MS Word, Excel, PowerPoint
5

Cpdm Regulatory Affairs Coordinator Resume Examples & Samples

  • Bachelor’s degree focused in biological, medical science or business such as Nursing, Biology, Public Health, Business Administration, or other related field of study
  • Two (2) years of clinical and/or regulatory research experience
  • Two (2) or more years of oncology research and/or academic regulatory experience
  • Experience with submissions to IRBs, and/or the FDA for IND or IDE
  • Experience working with Investigator Initiated clinical trials
  • Experience handling and prioritizing detailed tasks and meeting deadlines
  • Ability to problem solve and multi-task
  • Understanding of research standards as set forth by FDA, OHRP, UCH, UCD and NCI
  • Proficient in Windows, MS Word, Excel, PowerPoint
  • General understanding of Anatomy and Physiology and Medical terminology a plus
6

Regulatory Affairs Coordinator Resume Examples & Samples

  • Bachelor's degree in science required
  • One to three years of direct, industry-related Regulatory experience in relevant industries
  • Solid experience with Regulatory submissions (Rx and/or OTC) to FDA. Experience with interfacing with Regulatory agencies highly desirable. Experience with international Regulatory submissions and compliance a plus
  • Knowledgeable in current policies, practices, trends, technology, and information affecting the over the counter industry. Knows how the OTC environment works and has an awareness of competitors and their products
  • Introductory working knowledge of good manufacturing practices (GMPs), US pharmaceutical regulations, good clinical practices (GCPs) and good laboratory practices (GLPs)
  • Excellent team interaction skills along with demonstrated ability to work on a cross-functional team
  • Skilled in leveraging Microsoft Office programs and other relevant software
  • Participate in day-to-day operations of the OTC team, including ensuring all product and project-related milestones are met. Responsible for 2nd level label reviewer activities, maintain project plan oversight
  • Implement Regulatory strategies to ensure successful promotion and compliance, for marketed Healthcare products
  • Maintain close working relationship with the Global Regulatory Team to ensure alignment of local (US) Regulatory strategies with Global/Regional strategies
  • Provides Regulatory support and expertise to project teams, through Regulatory strategies and consultation on deliverables that could potentially impact the project/product
  • Ensure compliance with all internal and external regulatory requirements
  • Contribute to the evaluation and analysis of the impact of trends relative to government regulatory agencies
  • Participate in the preparation of major regulatory filings, and ensures timely completion of routine regulatory submissions required for maintenance of in-market products. Reviews technical reports prepared in support of regulatory filings
  • Maintains close working relationship with R&D, Medical, Supply, Legal and Marketing staff to support team structure and is responsibility for influencing growth and development of the brands within the therapeutic area
7

Product Stewardship & Regulatory Affairs Coordinator Resume Examples & Samples

  • Knowledge of chemistry is preferred
  • Organized and a strong attention to detail
  • Basic awareness / knowledge on Product Safety and Regulatory Affairs is preferred
  • Require strong communication, coordination, and documentation skills in a global and regional team environment
  • Good English on both written and spoken
8

Regulatory Affairs Coordinator Resume Examples & Samples

  • Administrative background, medical/scientific background is an asset
  • 1-3 years administrative or customer service experience preferred (Entry level accepted)
  • Good organization skills, effective time management, Autonomous
  • Active listener
  • Conscientious, Detail oriented
  • External Interactions with external manufacturers
  • Internal Interactions with Manufacturers Regulatory Affairs counterpart (BWIUS products and BWIIL products), EDC, Johnson & Johnson local regulatory affiliates in EMEA, marketing department, quality department, technical department, clinical department and finance department, Supply Chain / GMED
  • Fluent written and oral English communication skills
  • Good Computer skills: Outlook, Excel, Power Point
9

Regulatory Affairs Coordinator Resume Examples & Samples

  • Associates degree or greater
  • Experience with MS Office products and database applications
  • Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB
  • Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice
10

Regulatory Affairs Coordinator Resume Examples & Samples

  • High school graduate or equivalent with a minimum 9 years of progressively increasing administrative experience, at least 5 years of which must have been in a clinical research, regulatory, or technical environment
  • Hands-on regulatory administrative/clerical experience including use of regulatory related databases is required
  • A thorough knowledge and understanding of regulatory submission requirements, CTD format, TRDs and other related material is essential
  • An understanding of the information required for foreign regulatory submissions is desirable
  • Must have an understanding of and experience in utilizing medical and technical terminology in a regulatory environment
  • Must be fully cognizant of and responsive to shifting priorities and be able to interact with professional staff at all levels
  • Excellent organizational and verbal/written communication skills are necessary
  • Independent judgment, discretion and problem solving is required
  • Excellent computer skills and professional demeanor required for interactions with international colleagues and health authority representatives, including a working knowledge of database management as well as proficiency in Microsoft Word, Excel and PowerPoint
11

Regulatory Affairs Coordinator Resume Examples & Samples

  • Bachelor's degree in an applicable field
  • No experience required
  • Familiarity with medical and/or scientific terminology
  • Proficient in use of MS Office software packages, spreadsheet analysis, database analysis
12

Research Regulatory Affairs Coordinator Resume Examples & Samples

  • Prepares and submits research applications and performs regulatory study start up activities, drafts and or edits informed consents and other related documents, assists Principal Investigators (PIs) with protocol and document development, provides ongoing continuation reports to the Institutional Review Board (IRB) which include adverse event reporting, study amendment reporting, and coordination of submission to respective IRB. Conversely, a coordinator working with the Institutional Review Board will review, recommend changes or corrections, and prepare study related submissions for review by the IRB
  • Develops and maintains all regulatory documents including study amendments, recruiting material, continual reviews and safety reports per guidelines and regulations of the sponsor and the participating institution per IRB, FDA and other applicable Federal, State and local regulatory agencies
  • Serves as the regulatory representative and professional resource for any site-specific projects or those submitted to the IRB. Interacts on behalf of the physician investigators or the IRB with sponsors, research institutions, contract research organizations, regulatory agencies, and involved institutional departments
  • Responsible for the development and maintenance of the investigative sites study and regulatory documents and assures compliance with FDAs Good Clinical Practice guidelines. If employed as coordinator for the IRB, assures timely completion and filing of necessary Federal Wide Assurance (FWA) documentation with the Office for Human Research Protection (OHRP) and the annual report required by the Office of Research Integrity (ORI)
  • Functions as the established site point- person who provides information to the PI, Research director and study staff of submissions and approvals of study related documents. Maintains protocol status updates for pending and active projects. Functions as the site point-person for sponsors and Contract Research Organizations (CROs) to provide requested documents throughout the study existence and at monitoring and auditing visits conducted at the sites. Will be available to participate in site initiation visits for review of site regulatory binders. May be designated as the point-person for audits by regulatory agencies (i.e. OHRP, ORI, and FDA)
  • Coordinates daily operational activities consistent with the needs of clinical research staff or the Institutional Review Board to ensure timely submission of all regulatory documents and requests of sponsors. Engages in core measures of customer service and provides a professional example of the conduct of medical research to ensure human subject protection
  • May be required to conduct other administrative duties to support Research Directors or the Institutional Review Board Chair
13

Regulatory Affairs Coordinator Resume Examples & Samples

  • Submits, tracks and processes protocol amendments for National Clinical Trials Network (NCTN) studies within the required 90 day period
  • Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado Cancer Center. This may include, but is not limited to, the following
  • Colorado Multiple Institutional Review Board (COMIRB)
  • Western Institutional Review Board (WIRB)
  • NCI Central Institutional Review Board (CIRB)
  • Protocol Review and Monitoring System (PRMS)
  • Hospital Research Support Services (UCH-RSS)
  • University of Colorado Hospital Clinical Trials Office (CTO)
  • Completes and submits continuing reviews, amendments, and other protocol-
  • Navigates applicable NCTN websites. This may include Clinical Trials Support Unit (CTSU), Southwest Oncology Group (SWOG) and NRG Oncology (NSABP, RTOG, GOG)
  • Updates OnCore with regulatory documents and dates
  • Good command of the English language, in both written and verbal form. Proficient in Windows, as well as MS Word, Excel, PowerPoint
14

Regulatory Affairs Coordinator Resume Examples & Samples

  • Supervise workflow processes for the submission of regulatory documents
  • Ensure timely submission of these documents by bringing to management’s attention any problems, discrepancies and by offering any alternative solutions or more efficient workflow processes
  • Coordinate with Regulatory Submissions and Documentation on the preparation of regulatory submissions using current electronic publishing programs
  • Help to establish and communicate priorities of regulatory submissions to customers
  • May communicate with regulatory agencies or other consultants to coordinate the distribution and implementation of any new forms, SOPs, or current industry information to internal/external customers
  • Supervise and/or train other specialists in use of forms or new formatting requirements
  • Verify integrity of documents
  • Supervise the processing of document entry into the client’s document systems in a timely and efficient manner to guarantee confidentiality and accuracy for use in future submissions, in the event of an inspection by regulatory authorities, or during internal audits
  • Support and maintain any tracking databases using appropriate software packages as directed by regulatory management, or as required
  • Verify compliance with current SOPs and company policies
  • Distribute database systems for tracking of information to appropriate customers
  • Work with cross-functional management to gather and provide information on priority projects
  • Verify and coordinate quality control of submissions as well as proper compliance with department SOPs and Regulatory Authority guidelines
  • Provide appropriate training and encourage productivity and variety in assignments
  • Ensure adherence to SOPs, policies and procedures
  • Offer assistance to support staff when new programs are instituted by the Company
15

Regulatory Affairs Coordinator Resume Examples & Samples

  • Represents the company in all inspections, forum or meetings which has in anyway related to Product Regulatory affairs as may be deemed required by the company
  • Provides timely updates on new and latest memorandum from the office of Food and Drug Administration (FDA) for the Philippines affiliate
  • Assist in the verification of any inquiries related to Product Registrations of All Estee Lauder Brands marketed and to be marketed in the Philippines
  • Proactively monitor and track the availability of the Formulation to facilitate smooth and timely notification
  • Timely application / renewal of product notification with FDA
  • Responsible to properly maintain and update Product Information file (PIF) in accordance to Asean Cosmetics Directives and FDA Requirements
  • Responsible to properly maintain and update the Global Product Regulatory ST (PRST) on a timely manner
  • Collaborates with the Marketing team regarding the Advertising requirements related to New Product Launches and promotions
  • Assist the Sr. Supply Chain in raising the quarterly billing to TRD on regulatory services
  • Pro-actively participate in ad-hoc projects & streamline processes as identified during course of work
  • Participate in resolution of any constraints and issues related to product registration
  • College graduate and completed the Board of Pharmacy
  • Minimum of 1 year experience and active holder of Professional Regulatory Commission as Pharmacist or related profession
  • Attendance on Asean Cosmetics Directive and GMP Modules is preferable
  • He / She should be computer literate. Preferably with proficiency in Microsoft Excel
  • Willingness and openness to change processes
  • Customer Service Orientation
  • Flexible, positive, open-minded, very structured and precise
  • Good communication skills, written and verbal
  • Good organizational skills, time management and follow up skills able to prioritize and handle several tasks simultaneously
16

Regulatory Affairs Coordinator Resume Examples & Samples

  • Coordinate clinical trial initiation procedures including regulatory document submissions
  • Assure adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies
  • Assure staff and investigator training on and adherence to Department of Radiology clinical trials SOPs; maintain and update these SOPs
  • Assist with preparation and negotiation of study budgets, submission of confidentiality and clinical trials agreements to the Office of Grants and Contracts, and site initiation visits
  • Assist with recruitment and interview prospective subjects for clinical studies and educate potential subjects about the details of the study through phone contacts, personal interviews, and informed consent
  • Schedule subject visits and coordinate all personnel required for the visits when required
  • Collaborate with clinical staff in the hospital to ensure tests and procedures are scheduled and performed correctly; provide an initial orientation to new study protocols
  • Assure compliance with protocol requirements and complete necessary records. Accurately transfer source documentation into electronic Case Report Forms (CRF). Maintain all clinical research patient files
  • Recognize adverse and serious adverse events, and provide prompt notification to the appropriate parties
  • Prepare documentation for sponsor monitoring visits and FDA audits
  • Enhance research growth within the Radiology faculty by providing focused education programs including topics such as the IRB submission process and the availability of research resources
  • Educate new investigators and staff about clinical research regulatory and data collection requirements
  • Identify appropriate clinical trials for Radiology participation and facilitate faculty involvement
  • Assist with coordination of the tumor measurement and protocol review services and ensure adequate coverage during vacations and other absences
  • A Bachelor’s degree and a minimum of 1 year regulatory experience
  • Experience with industry sponsored clinical trials
  • Knowledge of Good Clinical Practice guidelines and FDA regulations
  • Experience with sponsor and/or FDA audits of clinical trials
  • Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task
  • Demonstrated knowledge of basic human anatomy, physiology, medical terminology, and computers
  • HIPAA and human subjects’ certifications
  • Experience with NIH sponsored clinical trials
  • Knowledge of study budgeting and billing processes
  • Experience working in the EPIC electronic medical record system
  • Experience working in the OnCore research management system
17

Regulatory Affairs Coordinator Resume Examples & Samples

  • Assist with audit preparations
  • Coordinate, obtain, legalize, compile and distribute documents needed to support global regulatory submissions. Organize and maintain submission and technical paper files
  • Generate and maintain database of product reference numbers vs. FDA submission, technical files, CE Mark, etc
  • Handle/manage process for license registrations. Research regulation requirements upon renewal
  • Maintain and renew FDA establishment registrations and product listings at Federal level
  • Prepare, request and track government certifications to ensure smooth transition with registration of new products in global market. Administer certification request system
  • Provide metrics and reports to support RA/QA needs, Management Review, Monthly reports, etc. Submit requisitions and process check requests with Accounts Payable
  • Review and update TIs and SOPs as related to product registrations, licensing, certificates and state registrations
  • Review state rules and regulations on annual basis and submit new and/or renew, revise pharmacy wholesale licenses throughout the U.S as applicable
  • Update and renew product listing and facility registrations with FDA and Health Canada
18

Regulatory Affairs Coordinator Resume Examples & Samples

  • Bachelor’s degree or higher in a Science discipline from an accredited institution
  • Minimum of two (2) years regulatory experience with drug and/or medical device products
  • Bachelor's degree or higher in Biology, Chemistry or related disciplined from an accredited institution
  • Previous experience with structured product labeling, electronic publishing, and electronic submissions
  • Detailed oriented, ability to navigate a matrix environment
  • Experience working on a cross-functional team
19

Regulatory Affairs Coordinator Resume Examples & Samples

  • Under general supervision, performs functions that require full knowledge of general aspects of the job
  • Assists with marketing materials review and submission process through CMS Health Plan Management System (HPMS) or CEC Portal
  • Maintains calendar management for HPMS submissions
  • Responsible for entering questions and answers in SharePoint which were researched by Regulatory Affairs
  • Responsible for creating and maintaining a library of CMS communications for ESCO business
  • Participates in Department’s initiatives to support the implementation of corporate quality goals and action plans
  • Provides day to day support to the FHP Regulatory Affairs Department ensuring timeliness, accuracy and efficiency in the completion of all pertinent regulatory functions and related projects
  • Supports the FHP Regulatory Affairs Department’s collaboration with the FMCNA Compliance and Corporate Law Departments to facilitate the development and implementation of programs, policies and procedures based on best practices and regulatory requirements
  • Escalates issues to supervisor for resolution, as deemed necessary
  • 1 – 2 years’ related experience
  • Preferred legal or regulatory experience in a Medicare Advantage program
  • Demonstrated skills in areas of communication, performance management, research and interpretation of regulations, and managing complex projects through matrix relationships
  • Strong personal computer skills
20

Commercial Compliance & Regulatory Affairs Coordinator Resume Examples & Samples

  • Bachelor’s degree in business administration, economics, healthcare administration, or other related field
  • 4 years of demonstrated successful experience working with administrative, policy and/or operational aspects of commercial health plans
  • 3 years of demonstrated success in progressive leadership roles and/or management experience
  • Consideration may be given for candidates who have an advanced degree in a related field, or comparable experience in lieu of a bachelor’s degree in the stated field
  • Consideration may be given for candidates who have comparable experience with administrative law and/or regulated industries
21

Regulatory Affairs Coordinator Resume Examples & Samples

  • Completion and submission of new clinical trials applications to the IRB
  • Writing plain language informed consent documents
  • Tracking and facilitating the progress of new trials through the review process
  • Correspondence with the IRB, investigators and sponsors throughout the review process
  • Collection, completion, and submission of regulatory documents to various regulatory entities
  • Creation and maintenance of regulatory binders and other relevant files during the review, approval, and activation process for new trials
  • Prior regulatory or clinical research experience with an academic medical center or industry preferred
  • Detail-orientation with the ability to manage multiple projects simultaneously
  • Candidates with no relevant experience will be hired as CRC I
22

Regulatory Affairs Coordinator, Compliance Resume Examples & Samples

  • Assists with the development and maintenance of master filing systems (submissions, compliance, government relations)
  • Proactively manages administrative aspects for the department
  • Labeling and Promotional Review
  • Work with cross-functional departments to coordinate label review materials
  • Prepare label review meeting agendas
  • Maintain labeling and promotional review databases
  • Coordinates review and release of final promotional materials for biotherapeutic portfolio
  • Prepares FDA 2253 submissions and submits to FDA with Supervisor approval
  • Assists with pharmacovigilance processing and tracking of all PV related costs
  • Provides support for audits by compiling requested documents, keeping records up to date and accurate (audit ready)
  • Assists with SOP processing and updates in Master Control
  • Verifies that RA department office supplies are maintained at adequate levels
23

Regulatory Affairs Coordinator Resume Examples & Samples

  • Coordinates the on-boarding and documentation of new research staff within the USO network. Assists Transitions and Disaffiliation internal team to deactivate profiles, mail and file documents. 40%
  • Coordinates collection of required documentation from research sites in accordance with FDA and trial sponsor specifications and tracks collection progress through CTMS and other task tracking systems. 30%
  • Prepares mail-outs to send to sponsors and quality checks documentation in document management systems to ensure files are complete. 15%
  • Schedules and attends internal and external business meetings to capture accurate meeting minutes and action items. 10%
  • Other duties as assigned. 5%
24

Regulatory Affairs Coordinator Resume Examples & Samples

  • Some knowledge of regulatory affairs requirements for distributors at the state and federal levels (i.e., BOP and FDA) would be beneficial; not rquired
  • Good decision making capabilities
  • Detail oriented and organized
  • Ability to Research and analyze applicable regulations
  • Proficient in MS Office Word, Outlook and Excel
  • Previous experience in healthcare, pharmaceuticals or clinical desired but not require
25

Dach Regulatory Affairs Coordinator Resume Examples & Samples

  • 20 % of time: Business Administration
  • Organization of travel, internal and external meetings including invoicing and budget control in adherence with company travel policy
  • Writing and distribution of meeting minutes
  • Prepare slide presentations, revise drafts for agency meetings
  • Organize incoming and outgoing mail
  • Structure and control of new meaningful regulatory IT infrastructure and Share Point folder lists to allow efficient team integration work
  • Overall budget control including regulatory fee oversight and fee retention calculation to Finance
  • Order management of office and IT related equipment
  • Create working instructions for IT business support applications and train them accordingly (COUPA, PEGA, SAP, etc.)
  • Respond to global or regional EU RA / Business enquiries by consolidating a harmonized DACH country response (table overviews) by outlook based on an individual action item (AI)
  • Support RA Lead DACH in any delegated AI relevant RA or business task
  • AOB
  • 20% of time: Administrative Regulatory Affairs support for EU LOC team
  • Support consolidation tasks at European LOC RA level on topics of common regional interest, under guidance of EU LOC RA Head
  • Ensure monthly key submission status / team highlight report input collection and final formatting and distribution
  • Support travel planning and expense management for DACH RA team and Head of EU LOC RA
  • 40 % of time: Technical RA support
  • Provide product related regulatory translations (German – English or vice versa) including agency communication, decisions
  • Proof reading of translated SmPC and PIL and related product labelling (artwork) according to regulatory standards (QRD template)
  • Responsible for updating all local health authority or non-health authority associations with most current prescribing information / SmPC versions etc. including update of compendia services (e.g. Fachinfo-Service, Rote oder Gelbe Liste in DE etc.),
  • Issue or update brief product PI labeling text for promotional material (“Pflichttext”) according to Heilmittelwerbegesetz (HWG) in close collaboration with Information Officer
  • Liaise with marketing and commercial to ensure that all local product information used are up to date
  • Update RA web page
  • Update product e-catalogue with most recent PI / SmPC information
  • Update company web page with RA specific information in close collaboration with Communications
  • Review and update the regulatory SOP system and related (external) training documentation
  • Provide IT related support for specific IT applications essentially needed to do RA business including brief trainings, generate working instruction sheet updates (e.g. Webex functionality, VCs, Promomats, VEEVA Registration tracking, e-product catalogue, PEGA, SAP, COUPA etc.)
  • 20 % of time: Product Labeling & AdProm Material review
  • Provide translations for review of AdProm Material
  • Review promotional material for compliance with standard of terms and local regulations in close cooperation with the Information Officer and / or product specialist
  • Support clinical trial applications or agency database update with study reports in close cooperation with product specialist
  • Number of years of experience: 3-5 years
  • Field of expertise: Office Management, regulatory affairs or equivalent experience within a pharmaceutical company, CRO, or similar organization
  • Loyal
  • Organised and structured
  • Keeping deadlines and commitments
  • Self-motivation
  • Very good written and verbal (English) communication skills
  • Knowledge of regulations
  • Oriented towards technical details
  • Proofreading and editing skills
  • Manage multiple tasks and deadlines
  • Resilient
  • Comply with company regulations / standards and protect Shire´s public reputation
  • German Excellent
  • English Excellent
  • French (would be an asset)
26

Regulatory Affairs Coordinator Resume Examples & Samples

  • Assist in preparation and submission of pre-study regulatory documentation to pharmaceutical
  • Assist in submission for UPMC General Clinical Research Committee and Magee-Womens Hospital Clinical Research Center
  • Assist in submitting new IND applications to the FDA
  • Communicate approval to appropriate individuals at cooperative group headquarters
  • Computer aptitude necessary to operate word processing, spreadsheets, etc. applications
  • Demonstrated regulatory skills, including knowledge of local and federal IRB submission processes
  • Facilitate processing and approval for cooperative group trails (GOG) new protocols and amendments
  • Interpersonal and communication skills necessary to establish and maintain effective relationships with staff, investigators and Institutional Review Boards
  • Knowledge of regulatory guidelines
  • Notify investigators and coordinators once approval has been obtained
  • Oversee processing of all protocol amendments in a timely matter
  • Prepare modifications for the IRB, revise protocol summaries and consent forms and complete the necessary steps for resubmission to the Board
  • Prepare protocols for submission to Institutional Review Boards, (University of Pittsburgh Medical Center, University of Pittsburgh Cancer Institute and Magee-Womens Hospital)
  • Process annual renewals with all of the Institutional Review Boards
  • Review and distribute the IRB's feedback to investigators
  • Submit adverse event reports and safety reports to the IRB
  • Submit termination notices and final progress reports to the IRB
  • Track the status of all protocols, from initial IRB submissions until final approval
  • Level of knowledge equivalent to that ordinarily acquired through completion of a BSN or Bachelors Degree in related field
  • Two years experience in Research and Regulatory Affairs division
  • Previous experience with IRB submissions for grant-funded studies is strongly preferred
27

Federal Regulatory Affairs Coordinator Resume Examples & Samples

  • Bachelor's degree, preferably in science, healthcare, or other related field. Significant experience in research coordination or regulatory work may be substituted for educational requirements
  • Minimum of two years of experience in healthcare, research or clinical setting with regulatory compliance familiarity
  • Working knowledge of computers, standard office software packages (Word, Excel, Access, Power Point, etc.), standard office equipment (photocopiers, facsimiles, telephones, pagers, etc.)
28

Regulatory Affairs Coordinator Resume Examples & Samples

  • Organize and maintain files/databases
  • Gather information and data from other departments and external resources for regulatory submissions
  • Assemble regulatory documentation for regulatory submissions
  • Register all Arthrex facilities and devices with the FDA
  • Order documents, subscriptions, articles, standards and other items
  • Coordinate office functions; maintain office supplies & equipment, copying, scanning, typing correspondence and meeting notes
  • Effective Project Coordination skills
  • Strong knowledge and understanding of Microsoft Office
  • Ability to work in fast paced environment and handle multiple tasks