Director Of Regulatory Affairs - 21449

• Independently prepare and coordinate briefing books and regulatory documents.
• Manage regulatory activities for a program or product, with oversight from the U.S.-based Regulatory Lead.
• Research, interpret, and apply health authority guidances, and provide clear regulatory recommendations to cross-functional teams.

• Contribute to program-level regulatory strategy, forming and communicating a point of view grounded in agency guidance.
• Identify regulatory risks and propose mitigations aligned with clinical, nonclinical, and CMC development plans.

• Coordinate regulatory submissions and amendments, including ongoing lifecycle activities such as annual reports.
• Ensure alignment across the clinical, nonclinical, and CMC components of submissions and support submission timelines.

• Support preparation for health authority interactions, including drafting regulatory questions, meeting objectives, and positioning.
• Document, interpret, and integrate health authority feedback into regulatory documents and development planning.
• Coordinate responses to health authority requests and manage related agency correspondence and follow-up.

• Author and support preparation of regulatory designation applications, such as Orphan Drug, Fast Track, and other applicable expedited programs.

• Monitor evolving regulatory guidance relevant to the portfolio and advise the team on implications.

• Bachelor's degree in life sciences or a related discipline.
• Minimum 10 years of experience in biotechnology or pharmaceutical development, including direct Regulatory Affairs experience.
• Hands-on experience with FDA submissions, with the ability to operate independently and without significant hand-holding.
• Demonstrated ability to independently prepare briefing books, coordinate submissions, and manage regulatory projects with limited oversight.
• Excellent written and spoken English, with the ability to draft regulatory documents and agency responses fluently and coherently.
• Experience researching and applying health authority guidance to provide regulatory recommendations to teams.

• Radiopharmaceutical experience strongly preferred.
• If not radiopharmaceutical, small-molecule regulatory experience is preferred over biologics.
• Experience supporting (not necessarily leading) FDA or EMA agency interactions and briefing books.
• Familiarity with EMA processes and CTIS (the EMA clinical study portal) is a plus; a candidate fluent in FDA submissions can learn this on the job.
• Advanced degree (MS, PhD, PharmD) in a life sciences discipline.
• Background at a global CRO or multinational pharma with exposure to FDA and EMA filings for global sponsors.

You are:

• Independent and self-directed — you can own a program with light oversight and drive it forward.
• A strong writer and communicator who can produce clear regulatory documents and represent the work fluently in English.
• Scientifically fluent — comfortable engaging clinical, nonclinical, and CMC colleagues as a peer.
• Grounded in guidance — you build recommendations from agency precedent, not guesswork.
• Comfortable in a lean, fast-moving environment where you wear multiple hats.