Regulatory Affairs Specialist

About the role

The Regulatory Affairs Strategist develops and executes regulatory strategies to support pharmaceutical product approval and lifecycle management. Acts as a key liaison with regulatory agencies, ensuring compliance and facilitating timely submissions for clinical trials, marketing authorizations, and post-approval changes. Collaborates cross-functionally with R&D, Clinical, Quality, CMC, and Commercial teams, providing regulatory guidance throughout all development phases. Requires strong knowledge of FDA regulations, international regulatory environments, and experience preparing regulatory documentation. Demonstrates strategic thinking, attention to detail, and the ability to navigate complex regulatory frameworks to support business goals.

Responsibilities

• Developing and implementing regulatory strategies for product pipelines, including NDAs, BLAs, and supplements.
• Drafting and submitting regulatory documents to FDA and international agencies.
• Interpreting and applying regulations, monitoring changes affecting product development.
• Providing regulatory guidance to cross-functional teams.
• Maintaining submission tracking systems, regulatory databases, and filings.
• Managing interactions with regulatory agencies and handling correspondence and meetings.
• Identifying and mitigating regulatory risks to ensure compliance and timeline integrity.
• Supporting global regulatory strategies and coordinating responses to agency requests.
• Working with CROs and internal teams on regulatory deliverables for US and international submissions.
• Communicating project updates to senior management and anticipating regulatory risks.
• Prioritizing projects aligned with company goals.

Qualifications

• Advanced degree in Life Sciences, PharmD, Regulatory Affairs, or related field.
• 5+ years of regulatory affairs experience in pharma, biotech, or medical devices.
• Deep knowledge of FDA and global regulations, with experience preparing submissions.
• Proficient in project management, communication, and negotiation.
• Experience with submission platforms, regulatory databases, and eTMF systems.
• Strong cross-functional collaboration, communication, and organizational skills.
• Detail-oriented, self-starter, and adaptable to a fast-paced environment.