Job SummaryThe Regulatory Affairs Strategist is responsible for developing and executing regulatory strategies that support the approval and lifecycle management of pharmaceutical products. This role serves as a key liaison between the company and regulatory agencies, ensuring compliance with applicable regulations while facilitating timely submissions for clinical trials, marketing authorizations, and post-approval changes.
Working cross-functionally with R&D, Clinical, Quality, CMC, and Commercial teams, the strategist provides regulatory guidance throughout all phases of product development. The ideal candidate will possess strong working knowledge of FDA regulations (including IND and NDA processes), international regulatory environments, and experience preparing regulatory documentation.
This position requires strategic thinking, attention to detail, and the ability to navigate complex regulatory frameworks to support innovation and business goals.
Job Responsibilities- Develop & implement regulatory strategies across product pipelines, including NDAs, BLAs, and supplements.
- Draft and submit regulatory documents (e.g. INDs, NDAs, CTAs) to the FDA and international agencies (Canada, Europe, UK).
- Interpret and apply regulations (FDA, ICH, cGMP, USP standards) and monitor changes that may affect product development.
- Provide regulatory guidance to cross-functional teams-R&D, clinical, CMC, quality, and commercial.
- Maintain submission tracking systems, regulatory databases, and filings.
- Interact with regulatory agencies, managing agency correspondence, meetings, and scientific advice requests.
- Identify and mitigate regulatory risks, ensuring compliance and protecting timeline integrity.
- Support global strategies, including alignment with non U.S. jurisdictions where applicable.
- Lead and manage responses to Health Authority information requests.
- Work with CROs, consultants, and the internal team as required to plan, manage, and support regulatory deliverables related to US and EX-US submissions for assigned projects.
- Interface with senior management to provide project updates.
- Anticipate regulatory risks and propose mitigation strategies.
- Coordinate and prioritize assigned projects according to company goals.
Qualifications- Advanced degree in a scientific discipline required (Life Sciences, PharmD, Regulatory Affairs, or related).
- RAC certification is a strong plus.
- 5+ years of regulatory affairs experience-pharma, biotech, or medical devices.
- Deep knowledge of FDA requirements and global regulations.
- Track record in preparing and submitting regulatory filings.
- Proficient in project management, communication, and negotiation.
- Experience with submission platforms, eTMF, and regulatory databases.
- Excels at cross-functional collaboration and facilitates effective communication and alignment across diverse teams.
- Excellent oral and written communication skills.
- Experience developing and implementing successful regulatory strategies.
- The candidate should be detail oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
