Regulatory Job Description
Regulatory
provides regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials, including representation on global regulatory and labeling teams.
Regulatory Duties & Responsibilities
To write an effective regulatory job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory job description templates that you can modify and use.
Sample responsibilities for this position include:
Communicate with contract manufacturers and consultants as appropriate to ensure adherence to regulations and internal procedures
Individual will be responsible for obtaining/reviewing data produced around the rules, policies, and procedures that are a result of the current and ever-expanding regulatory legislations
Provide regulatory support, guidance and expertise to internal groups to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned
Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives
Support the development of all new products and re-formulations through research on applicable regulations
Monitor new Fund launches and new rules to determine Regulatory Requirements
Process all adverse event reports pursuant to internal procedures
Producing quarterly financial information for inclusion in the firm’s consolidated SEC financials
Performing and provide leadership within the monthly closing process
Assessing on a quarterly basis the effectiveness of internal controls and escalating control issues to senior management
Regulatory Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory
List any licenses or certifications required by the position: CITI, UL, ETL, RAC, CPIA, ACRP, B.S, CIP, RAPS, CE
Education for Regulatory
Typically a job would require a certain level of education.
Employers hiring for the regulatory job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Business, Engineering, Finance, Education, Accounting, Economics, Science, Geoscience, Chemistry, Life Sciences
Skills for Regulatory
Desired skills for regulatory include:
Regulations
FDA
Excel
Drug development process
Regulatory requirements
Drug development
Policies
EU
PowerPoint
Procedures
Desired experience for regulatory includes:
Liaising extensively with other areas of firm such as Product Controllers, Funding Controllers, Corporate Treasury, Legal, Tax, Regulatory, Market Risk and Credit Risk on various ad hoc inquiries
Performing ad hoc analyses on financial and non-financial attributes of consolidating legal entities for internal and external reporting purposes
Potentially liaising with global LECs on various Firmwide disclosures
Calculating and analyzing the regulatory capital requirement
Analyzing movement in regulatory capital requirement over longer periods
Ensuring accurate and complete reporting of regulatory information in public reports to the US regulatory authorities
Regulatory Examples
1
Regulatory Job Description
Job Description Example
Our company is hiring for a regulatory. 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
- Create the regulatory requirements for artwork template, proof artwork and approve
- Perform various month-end calculations pertaining to 15c3-1 capital charges
- First level review of all regulatory reports, including FOCUS report, 15c3-1, 15c3-3, Fed Form S, Fed TIC B, and SEC 17-H filings
- Assisting in FINRA examinations and responding to queries from regulatory bodies with respect to the Broker/Dealer Financial Reporting
- Acting as a liaison with business unit accounting teams to maintain US GAAP books for the Broker/Dealer
- Assist in month end close for the Broker/Dealer including the review of balance sheet and P&L analysis
- Assist with external audits and internal audit reviews
- Acting as a liaison with business, Operations and IT to improve data integrity for financial reporting and regulatory reporting
- Participating in projects that improve controls, processes and system enhancements for the broker dealer
- Maintain Ingredient/Product Database with material specifications and ingredient information from suppliers - in conjunction with Product Development and Scientific Affairs
Qualifications for regulatory
- College graduate with Engineering or science degree or equivalent experience
- Qualified systems lead auditor for ISO 13485 and MDD compliance
- Minimum of 3-5 years experience in a Medical device regulatory affairs role
- 2+ years of banking experience with internal controls or regulatory reporting
- Experience with loans, leases, and/or derivatives preferred
- 2+ years of Public Accounting experience with Brokerage clients
2
Regulatory Job Description
Job Description Example
Our innovative and growing company is looking for a regulatory. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory
- This position is critical to insuring support of product and package compliance to applicable regulations
- File required submissions with appropriate regulatory agency(s)
- Provide support to the international team as necessary for product registrations
- Stay abreast of and provide input on changing Regulatory environment
- Review and approve quality documents on behalf of regulatory
- Review and approve marketing materials (social media posts, sell sheets, print ads)
- Utilize knowledge of regulatory environment to conduct thorough research for regulatory processes
- Interface with third party service providers, medical consultants and contract manufacturers to perform job responsibilities
- Operate within defined structure to develop and maintain ingredient database
- Follow SOPs to perform Adverse Event responsibilities
Qualifications for regulatory
- Ability to work to deadlines and on own initiative
- Educated to a minimum of Graduate degree level
- Part qualified/qualified accountant- (ACCA, ACA, CIMA)
- PC/ FC or regulatory background
- COREP knowledge is beneficial
- Investment Banking or Audit background
3
Regulatory Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of regulatory. 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
- Developing a good working knowledge of oil & gas production, revenue settlement, and general ledger accounting concepts and reporting regulations and requirements
- Develop and author Technical Files and other regulatory communications conveying all necessary technical detail and adherence to applicable regulatory standards and internal standard operating procedures (SOPs)
- Ownership of tasks within daily, monthly and quarterly regulatory reporting required by local regulatory bodies in region
- Performance of daily tasks to tight deadlines, and where possible enhancement of process
- Review of static data classifications to ensure reporting rules are met
- Reconciliations and data quality exercises to enhance the quality of our reporting output
- Ability to identify process weaknesses and actively work with the team to address
- In addition to these functions, employees are required to carry out such other duties as may reasonably be required and therefore need to be flexible to the changing challenges faced by the department
- Liaising with various teams
- Oversee the internal AE processes, third party services and medical consultants
Qualifications for regulatory
- Background in Technical, Scientific or Medical / Health Discipline or equivalent experience
- Part qualified accountant, with a desire to qualify
- Self-motivated with the ability to work independently within a team structure
- Fast leaner and a keen eye for the detail
- Desire and energy to develop within the organisation and to gain promotion
- Analyze data and advise regulatory, quality and management team of any significant trends identified
4
Regulatory Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of regulatory. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory
- Reporting to the Regulatory Reporting Manager, but working very closely across the finances teams
- Finalise implementation of AIFMD
- Ensure the FATCA project, and similar arrangements expected from other governments, are brought to conclusion
- Review and ensure consistency in FCA reporting, supporting regulatory company accountants as required
- Work closely with third-party manufacturers in order to ensure they put in place PIFs and any other documentation that’s required for International compliance
- Ensuring that all product and website claims are consistent with best practice in the industry
- Working with the regulatory coordinator and understanding the companies international distributors to provide information and data that is needed to ensure compliance in other territories
- Coordinate and review Safety assessments for existing and new products
- Managing the daily running of new product development regulatory activities within the timings of the critical path
- Preparing for and attending NPD meetings and managing NPD next as required
Qualifications for regulatory
- Investment advisory compliance experience, direct federal and/or state regulatory experience preferred
- Good knowledge and understanding of Derivative products and counterparty risk management processes, such as CSAs, collateral
- Minimum 2 years experience in a fast-paced, technical, product development, or manufacturing environment
- 3-5 years experience in dealing with regulators preferred
- 3-5 years of experience in regulatory toxicology and human risk assessment is preferred but will consider an early career PhD who has in interest in pursuing a job in industry and in developing regulatory expertise
- Support the Financial Controllers of the UK regulated entities as they populate templates used in the production of the main regulatory returns
5
Regulatory Job Description
Job Description Example
Our growing company is looking for a regulatory. 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
- Updating and monitoring all NPD related actions and ensuring timely completion
- Tracking the receipt of new product samples, and how these are distributed within the business whilst co-ordinating user trials with technical team
- Implement all regulatory technologist activities onto Coptis with accuracy and accountability
- Assist in preparing label source documentation
- Obtains NDA approval as per the declared regulatory plan, maintains a compliant insert leaflet for the product of concern, ensures no shipment interruptions due to regulatory reasons, maintains up to date regulatory plan for the products of concern
- Acts in compliance with SOP/ LSOP
- Maintains a compliant leaflet in the markets
- Supports in CAPA actions when needed
- Abides by the local country laws
- Ensures the personal LOS KPIs are met
Qualifications for regulatory
- Prepare several of the FSA forms for the UK regulated entities
- Prepare the daily capital adequacy assessment for the UK consolidated entity
- Ensure that regulatory reporting processes adhere to the Group’s internal control standards and that appropriate audit evidence is maintained
- Develop relationships with internal stakeholders (Business, Finance, Risk, Legal & Compliance) in order to improve the quality, efficiency and effectiveness of the team
- Provide ad hoc regulatory support to senior management and the business as required
- Ability to work under pressure, while maintaining high levels of numeracy and accuracy