Senior Director, Regulatory Affairs

Artbio•Cambridge, MA

About The Position

The Senior Director, Regulatory Affairs leads and coordinates regulatory interactions and submission execution for ARTBIO’s clinical-stage radiopharmaceutical programs. This role is primarily responsible for coordinating regulatory medical writing across functions. The position works cross-functionally to translate research and development data and strategy into clear, compliant regulatory communications and high-quality submission deliverables.

Requirements

Bachelor’s degree in a scientific, medical, pharmacy, or related discipline is required.
12+ years of progressive regulatory affairs experience in the biotech or pharmaceutical industry, including demonstrating leadership in leading the deliverables for regulatory interactions supporting pre-IND to Phase 3 investigational-stage programs in oncology.
Strong knowledge of US FDA requirements and interaction processes
Proven track record coordinating US INDs, IND amendments, annual reports, health authority meeting packages, and responses to US FDA information requests.
Hands-on experience with electronic submission publishing, document management, submission standards, and external publishing vendors.
Clear, concise communicator with strong scientific judgment and exceptional writing and editing skills.
Highly organized, proactive, and detail-oriented, with disciplined follow-through on commitments and timelines.
Comfortable working in a fast-paced biotech environment with evolving priorities and multiple stakeholders.
Collaborative leader who can align subject matter experts, challenge constructively, and drive decisions without losing momentum.
Commitment to quality, compliance, and patient safety.

Nice To Haves

An advanced degree is preferred.
Experience and familiarity with leading submission of New Drug Applications, Marketing Authorization Applications, and radiopharmaceutical development are helpful.

Responsibilities

Serves as the point of contact for Health Authorities.
Translates program regulatory strategy into clear interaction plans, submission plans, timelines, and cross-functional deliverables for ARTBIO’s clinical-stage radiopharmaceutical programs.
Leads the preparation, coordination, and delivery of regulatory submissions, including INDs, IND amendments, annual reports, meeting requests, CTAs, and other lifecycle submissions.
Schedules and coordinates meeting rehearsals prior to Health Authority interactions.
Finalizes meeting minutes with Health Authorities, responses to information requests, and follow-up actions.
Oversees publishing and submissions.
Partners with Clinical, Medical, CMC, Quality, Nonclinical, Clinical Operations, and other contributors to develop content, resolve data gaps, and maintain an aligned submission narrative.
Maintains clear records of correspondences, commitments, decisions, and submission history.
Establishes and maintains regulatory plans, workflows, submission calendars, trackers, and archives.