Regulatory Affairs Director

Summary

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.

Key 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.

Qualifications & Education

• Bachelor’s degree in a scientific, medical, pharmacy, or related discipline is required; an advanced degree is preferred.
• 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.
• Experience and familiarity with leading submission of New Drug Applications, Marketing Authorization Applications, and radiopharmaceutical development are helpful.

Personal Attributes

• Clear, concise communicator with strong scientific judgment and exceptional writing and editing skills.