Senior Director, Regulatory Strategy – Radiopharma

ARTbio; United States; Remote; USD 230,000 - 300,000; Full time

Job summary

ARTBIO is a clinical-stage radiopharmaceutical company seeking a Senior Director, Regulatory Affairs to lead regulatory interactions and submission execution. The role focuses on coordinating regulatory medical writing across functions and translating R&D data into compliant regulatory communications.

You will manage INDs, amendments, annual reports, meeting requests, and other lifecycle submissions, while guiding cross-functional teams to ensure high-quality narratives and regulatory compliance.

Qualifications

• Bachelor’s degree in a scientific, medical, pharmacy, or related discipline is required; advanced degree preferred.
• 12+ years of progressive regulatory affairs experience in biotech/pharma, with leadership in regulatory deliverables.
• Strong knowledge of US FDA requirements and interaction processes.

Responsibilities

• Serve as the point of contact for Health Authorities.
• Translate regulatory strategy into interaction and submission plans with timelines.
• Lead preparation and delivery of regulatory submissions (INDs, amendments, annual reports, CTAs).
• Coordinate meeting rehearsals and finalize minutes with Health Authorities.
• Oversee publishing and submissions, ensuring compliant narratives.
• Collaborate with Clinical, Medical, CMC, Quality, and other teams to close data gaps.
• Maintain records of correspondences and submission history.
• Establish regulatory plans, workflows, calendars, trackers, and archives.

Skills

Regulatory strategy

Cross-functional leadership

US FDA requirements knowledge

Regulatory writing coordination

Project management

Education

Bachelor’s degree in a scientific, medical, pharmacy, or related discipline

Advanced degree preferred

Tools

Electronic submission publishing

Document management

Submission standards

External publishing vendors

Job description

ARTBIO is a clinical-stage radiopharmaceutical company seeking a Senior Director, Regulatory Affairs to lead regulatory interactions and submission execution. The role focuses on coordinating regulatory medical writing across functions and translating R&D data into compliant regulatory communications.

You will manage INDs, amendments, annual reports, meeting requests, and other lifecycle submissions, while guiding cross-functional teams to ensure high-quality narratives and regulatory compliance.