Regulatory Affairs Director

Job Summary

Leading the regulatory function for clinical-stage radiopharmaceutical programs, the full-time salaried Head of Regulatory Affairs will define global regulatory strategy, manage key submissions, and engage with health authorities while working remotely.

Key Responsibilities

• Define and lead global regulatory strategy for clinical-stage radiopharmaceutical programs
• Lead key regulatory submissions, including INDs, CTAs, and DMFs
• Serve as the primary point of contact for regulatory agencies and build strong relationships with key regulatory authorities

Required Qualifications

• Advanced degree (JD, PhD, PharmD, MD or equivalent) in a scientific discipline is preferred
• 15+ years of regulatory affairs experience in the biotech or pharmaceutical industries
• In-depth knowledge of global regulatory requirements and guidelines, including FDA and EMA regulations
• Proven track record of successful regulatory submissions, including INDs, NDAs, and BLAs
• Experience leading regulatory affairs strategies for complex programs across multiple therapeutic areas