Regulatory Operations Job Description
Regulatory operations
provides leadership for procedures on compiling and electronic publishing submissions including BLA, NDA, INDs and to FDA OPDP.
Regulatory Operations Duties & Responsibilities
To write an effective regulatory operations job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory operations job description templates that you can modify and use.
Sample responsibilities for this position include:
Correspond with the appropriate Federal or State Agency regarding registration submissions
Prepare status reports, conduct meetings to follow-up on issues
Work to ensure risks are mitigated and actions are delivered in targeted timeframe
Facilitate and drive communication to gain input and consensus from stakeholders in multiple teams and regions
Develop global partnerships across Operations and the business area in order to help implement initiatives
This role requires someone who can liaise with various groups supporting the businesses to design, implement, and manage regulatory reporting across the globe
Execute strategy and provide regulatory support and input
Collect and collate data required for registration submissions
Prepare submission packages for the appropriate Regulatory Agency
Assess impact of new regulations and guidance
Regulatory Operations Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Operations
List any licenses or certifications required by the position: PMP, RAC, LEAN, FEMA, BCSI, RAPS, SSL, CDCS, CTB, GRA
Education for Regulatory Operations
Typically a job would require a certain level of education.
Employers hiring for the regulatory operations job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Business, Science, Finance, Education, Accounting, Engineering, Medical, Technical, Life Sciences, Financial Services
Skills for Regulatory Operations
Desired skills for regulatory operations include:
Adobe Acrobat
Health authority procedures/guidance's regarding electronic submissions
Electronic document management systems
Equities
Excel
NDA
State
Guidelines
Both paper and electronic
CTD requirements and guidelines
Desired experience for regulatory operations includes:
Ability to deliver while working under pressure to tight deadlines
Assist in all activities for due diligence letter processing and develop sound navigation skills in all applicable systems
Provide customer support for property claims, following all required KYC and obtaining appropriate documentation through secure channels
Contribute to the documentation of procedures for all related processes
Prepare and post journal entries, reconciliations and Proof of Accounts as required, including semi-annual reconciliation of escheat cycles
Foreign Exchange product and industry experience
Regulatory Operations Examples
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Regulatory Operations Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of regulatory operations. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory operations
- Adjust and monitor timelines to support the business
- Execute systems integration for optimal functionality and use
- Monitor trade associations and task forces that support the company
- Monitor ongoing legislative and competitive developments
- Monitor and gain an understanding of new policies and objectives involving federal and local government affairs
- Review trade association materials (newsletters, meeting minutes, agenda items) to gain an understanding of where influencing opportunities exist
- Driving and delivering process change
- Status reporting – core team and senior management
- Liaising with other project teams and technology groups to ensure projects run to schedule
- Experience in a Business Analysis and Testing role
Qualifications for regulatory operations
- This role has overall responsibility for ensuring compliance with all global and local regulation in Americas GM Operations
- The jobholder must establish good working relationships with the members within Global Markets Operations and other project stakeholders (including IT, and other business contacts like Compliance, Finance, Product Control, Risks, and Front Office) in particular, effective relationships with senior Operations management across the globe senior members of the NY office such as CCO and COO are critical
- Knowledge of the current trade reporting environment in Europe, the US and Asia
- Understanding of the trade lifecycle from execution to confirmation/settlement
- Knowledge execution platforms and SEFs, plus CLS, SWIFT and other confirmation platforms
- Awareness of key trade processing risks and controls and the use of critical thinking and process analysis
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Regulatory Operations Job Description
Job Description Example
Our growing company is hiring for a regulatory operations. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory operations
- Prior experience in an operations regulatory oversight, assurance, control or compliance function would be preferable, although an individual who is established in change regulatory project management, business analytical and / or operational management experience will also be considered
- Recent experience in recent regulatory compliance preparation, for example EMIR, MiFID I, MiFID II / MIFIR, SFTR, MMSR, SMR would be advantageous
- Technical knowledge of regulated / conduct activities within an investment banking environment in either an operational or advisory capacity
- Broad financial services background with a proven record of stakeholder management across a diverse range of geographies and functions
- Coordinating with the Compliance and Regulatory Management Group, to perform an initial assessment of new regulatory reform affecting COO
- Capturing and maintaining the inventory of new regulations impacting the operating region and/or originating from the Financial Conduct Authority (FCA), Pridential Regulation Authority (PRA) and Central Bank of Ireland
- Identifying, engaging, advising and training the COO line on practicable rule interpretation and the coordination of feedback for regulatory consultations
- Collaborating with the COO Line to conduct impact and gap assessments of rule requirements against current and to-be operating and technology processes
- Challenging business requirements on adherence, including the design of appropriate controls and operating model
- Monitoring the timing & approach of project plan deliverables versus regulator expectations
Qualifications for regulatory operations
- Building strong networks across Derivative Operations, Technology and Project Leads
- Minimum three years of business experience in financial services
- Ensure the regulatory requirements of individual states for the escheatment of unclaimed property are met and manage technical solutions to meet those requirements
- Develop solid working relationships with many other areas of the firm including the Front Office, Technology, Legal, Compliance, interaction with external clients and regulators to support various reporting functions
- Establishing and overseeing daily responsibilities of the Quality Control Group including liaison with Internal Audit to ratify the model we are implementing
- Expertise in order, transaction and position reporting
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Regulatory Operations Job Description
Job Description Example
Our innovative and growing company is looking for a regulatory operations. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory operations
- Act as first level help desk to provide general support with respect to processes and operational activities
- 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, and, thus, is responsible for ensuring global submissions life cycle management for the Pacira product portfolio in order to reach Pacira business goals
- Ensures global coordination of planning data and the maintenance of schedules for submissions such as NDAs, CTAs/INDs, PSURs, changes/variations 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)
- Performs submission build activities, including, but not limited to, ensuring submissions are built with submission-ready documents, creating inter-document links, QCing and validating compiled submissions, and submitting by target date
- May support document formatting, publishing, and archive activities as needed
- Define and deliver the strategy for the regulatory operations team as it relates to delivery on the business
- Establish relationships with key partners such as sites, central IRBs, project management, safety and quality leadership and teams
- Understand content and necessary documentation for IRBs and Regulatory Submissions to US
- Define and manage regulatory operations needs and establish contingency plans for key resources
Qualifications for regulatory operations
- Bluesheets, TRACE, MSRB Submission, INSITE, OATS, Rule 605 and 606, ACT, LOPR, Large Trader Report
- Leadership of day to day Regulatory reporting requirements and activities
- Oversight of Bank of Canada and Tax authority reporting activities
- FX/FXO trade lifecycle experience
- Managing UAT cycles and issue management
- Good IT and technical knowledge
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Regulatory Operations Job Description
Job Description Example
Our company is hiring for a regulatory operations. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory operations
- Understand top line project issues and serves as the key point of escalation
- Work with management team to develop and track performance metrics for Regulatory Operations and Trial submissions
- Develop and maintain processes to support the quality and efficiency of the regulatory functional area
- Act as a resource person to troubleshoot problems with process or staff
- Identify and present project related issues and facilitates resolutions both in and across function
- Works with management team in development of status and progress reports metrics
- Promote effective teamwork among Regulatory Operations Staff
- Assures completeness and quality of submissions from the technical and operations perspective
- Participates in User Acceptance Testing (UAT) (running scripts, taking screenshots, ) for implementation and updating of various GRO systems
- Using available technical documents, prepare educational presentations related to newly passed legislation such as PDUFA VI
Qualifications for regulatory operations
- Experience in improving processes and increasing efficiency
- Self motivated, independent thinking with sound judgment, and yet willing to work as part of a direct or remote team
- A clear analytical thinker with the ability to work to stringent regulatory deadlines and commitments
- A good understanding of the current regulatory landscape and the forthcoming regulatory changes impacting Operations and Technology within investment banking, securities servicing and asset management
- Prior experience in an operations regulatory oversight, assurance, control or compliance function (beneficial)
- Recent experience in recent regulatory compliance preparation (beneficial)
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Regulatory Operations Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of regulatory operations. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory operations
- Appliance and strict adherence to all internal and external guidelines / policies and regulatory directives SLA’s, KRI’s and / or KPI’s and Quality measurements
- Prepare overview presentations on US Regulatory Policy updates
- This position will manage internal Regulatory Operations personnel the activities of external consultants
- 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
- This position requires the ability to exercise discretion, independent judgment and clearly identify priorities, to work overtime in order to meet required timelines
- Provide strategic CMC, pre-clinical and clinical regulatory insight to the project team regarding product development
- Prepare (proofread, format, PDF conversions, ), coordinate, and/or maintain regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSURs/annual reports, meeting packages, ) in accordance with applicable regulations
- Develop and maintain timelines
- Adjudication and finalization
- Provide regulatory support for regulatory activities, as needed
Qualifications for regulatory operations
- A broad financial services background with a proven record of Stakeholder management, across a diverse range of geographies and functions
- Education to degree level with relevant professional qualifications (beneficial)
- BA/BS or higher in science related field, public health, or regulatory related majors
- Demonstrated ability to work to work under tight and changing deadlines
- Recent, hands on experience with the tracking, compilation, publishing and submission of US INDs and NDAs
- Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills