Job Description
Job Description
Job Summary
Manage all regulatory activities for the company. Develop and implement regulatory strategies for internal product development. Work with partners representing company's interests and support partners' filing and regulatory activities. Provide counsel to other R&D and Commercial product team members. Ensure timely preparation of organized and scientifically valid regulatory documents and submissions. Provide expertise in translating regulatory requirements into practical, workable plans. Contact person for regulatory agencies. Manage regulatory document system, including the archival storage and protection of regulatory filings.
Responsibilities
- Develop and implement regulatory strategies for successful submission of product candidates from pre-IND stage through the product approval process.
- Collaborate with project teams to ensure regulatory compliance throughout the product development and product lifecycle.
- Direct regulatory activities for maintenance and continued compliance of commercial products.
- Serve as the liaison for regulatory authorities.
- Work with partners on their regulatory submissions, including attendance of recurring meetings and document preparation for sections that the company is responsible for
- Act as company PV/Drug Safety representative and point of contact with external partners.
- Provide leadership to direct report(s) and regulatory guidance to project teams
- Prepare regulatory submissions (e.g. IND, NDA, Technical File) by coordinating work cross functionally on data requirements to create content within a timely manner.
- Develop sound internal policies, standards and strategies related to submissions and identify risks associated with that strategy.
- Review and approve regulatory submission documents to ensure compliance with industry and regulatory standards.
- Maintain IND, NDA, and other regulatory submission documents including tracking of all regulatory interactions.
- Manage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to regulatory information requests).
- Provide regular updates and progress reports to the Executive Team and project teams.
- Establish and maintain regulatory SOPs.
- Regulatory surveillance and monitoring to ensure compliance with current regulations.
- Work with SMEs to assess impact of new or revised regulations on procedures and programs.
Skills Required
- Previous work with FDA on regulatory submissions (work with EMA, CDE, Notified Body, etc. is a plus)
- Must have IND filing experience and regulatory submissions related to clinical studies; direct regulatory experience supporting commercial products (NDA experience) is a plus
- Experience with drug safety and pharmacovigilance is preferred
- Hands-on experience preparing domestic and international regulatory submissions, ideally for both pharmaceutical drug-device combination products and medical devices.
- Excellent written and verbal communication skills for effective communication of complex regulatory issues.
- Effectively communicate risks/benefits of available options to address such complex issues.
- Excellent organizational skills and the ability to work in a hands-on environment.
- Ability to collaborate with multi-disciplinary teams to effectively assemble large volumes of accurate data for regulatory (and other) submissions.
- Ability to work with partners collaboratively and constructively for regulatory filings where partner is responsible for the dossier
- Solid background in pharmaceutical science and experience applying that knowledge to complex regulatory issues, including CMC, pre-clinical, and clinical aspects.
- Strong leadership skills and the ability to work effectively in project teams.
- Strong analytical, evaluation, and interpretation skills
- Ability to work in a fast-paced environment within milestone driven timelines.
Education and Experience
- Bachelor's degree in scientific discipline (Chemistry, Biology, biotechnology or related field) or commensurate experience; advanced degree preferred.
- 10 to 12+ years of relevant senior regulatory experience in the biotechnology/pharmaceutical industry with direct regulatory affairs experience with drug/device combination products from pre-IND to NDA
- Familiarity with 21 CFR Part 210, 211 and 820, ISO 13485, EU MDR 2017/745 and other regulatory standards related to drug-device combination products.
- Experience with authoring documents for regulatory submissions (IND, NDA, Annual Reports, Supplements, Technical Documentation File).
- Proven track record of producing clear and concise documents that effectively communicate complex information.
- Experience with commercial products, Drug Safety/ Pharmacovigilance (adverse event reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market surveillance
- Proficient written and verbal communication skills.
- Strong project management skills to manage complex regulatory project and meet deadlines.
- Regulatory certification or training preferred
- Experience in GMP-regulated pharmaceuticals, medical devices, or other regulated industry environment