Director, Regulatory Affairs Writing

Kiniksa Pharmaceuticals • Lexington, MA

6h • $223,000 - $236,000 • Hybrid

About The Position

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 role is hands‑on, fast‑paced, and central to the success of global submissions.

This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days (Monday - Thursday) in the office, and 1 day (Friday) remote.

Requirements

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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree