Executive Director, Regulatory Affairs (Radiopharmaceuticals)

ARTBIO; Cambridge (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

ARTBIO seeks a Senior Director, Regulatory Affairs to lead regulatory interactions and submissions across clinical-stage radiopharmaceutical programs. You will coordinate medical writing and translate R&D data into compliant regulatory communications, guiding high-quality INDs, amendments, annual reports, and lifecycle submissions.

You will partner with Clinical, Medical, CMC, Quality, and other functions to maintain submission narratives, regulatory plans, trackers, and archives, ensuring

Qualifications

• Bachelor’s degree in a scientific, medical, pharmacy, or related discipline
• 12+ years of progressive regulatory affairs experience in biotech/pharma
• 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 leading submissions of New Drug Applications, MAAs, and radiopharmaceutical development

Responsibilities

• Serve as the point of contact for Health Authorities
• Translate regulatory strategy into interaction plans, submission plans, timelines, and deliverables
• Lead preparation, coordination, and delivery of regulatory submissions (INDs, amendments, annual reports, meeting requests)
• Schedule and coordinate health authority meeting rehearsals
• Finalize meeting minutes and responses to information requests
• Oversee publishing and submissions
• Collaborate with Clinical, Medical, CMC, Quality, and others to develop content
• Maintain submission history and regulatory plans, trackers, and archives

Skills

Regulatory leadership

US FDA knowledge

IND submissions

Regulatory writing coordination

Cross-functional collaboration

Education

Bachelor’s degree in a scientific/medical/pharmacy field

Advanced degree preferred

Tools

Electronic submission publishing

Document management systems

Job description

ARTBIO seeks a Senior Director, Regulatory Affairs to lead regulatory interactions and submissions across clinical-stage radiopharmaceutical programs. You will coordinate medical writing and translate R&D data into compliant regulatory communications, guiding high-quality INDs, amendments, annual reports, and lifecycle submissions.

You will partner with Clinical, Medical, CMC, Quality, and other functions to maintain submission narratives, regulatory plans, trackers, and archives, ensuring