Director, Regulatory Affairs Writing

Role Summary

We are seeking a highly skilled Director, Regulatory Affairs Writing to serve as a senior individual contributor responsible for authoring and delivering high-quality regulatory documents that support global clinical development and product registration. This hands-on, fast-paced role is central to the success of global submissions. This role is based in Lexington with a hybrid schedule of four in-office days (Monday–Thursday) and one remote day (Friday).

Responsibilities

• Lead the planning, writing, and finalization of core regulatory documents, including IND/CTA content, clinical modules for NDA/BLA/MAA, CSRs, clinical summaries, IBs, briefing documents, protocols, and amendments.
• Drive health authority (HA) Request for Information (RFI) responses, coordinating SME input and ensuring timely, accurate, and aligned messaging.
• Prepare documentation for HA interactions, including meeting packages, talking points, and post-meeting summaries.
• Ensure documents meet ICH, FDA, EMA and other global regulatory standards, with strong focus on clarity, data accuracy, and message consistency.
• Collaborate cross-functionally to integrate clinical, statistical, and safety data into clear, compelling narratives.

Qualifications

• Required: 10+ years regulatory writing experience in biopharma, with authorship of major regulatory submissions.
• Required: Proven experience developing responses to FDA/EMA HA questions and supporting agency meetings.
• Required: Exceptional writing, critical thinking, and document leadership skills.
• Preferred: Advanced scientific degree (MS, PharmD, PhD).