Translating medicinal chemistry insights into next-generation radioligand therapies (RLTs)
Global Regulatory Head
Location
Massachusetts
Posted
93 days ago
Salary
$150K - $275K / year
Seniority
Lead
Job Description
Global Regulatory Head
Actithera
• Author and compile briefing books for regulatory meetings • Lead the preparation, submission, and maintenance of INDs, CTAs, and amendments • Formulate global regulatory strategies, including accelerated pathways for RLT assets • Represent the company in interactions with FDA, EMA, PMDA, and other agencies • Ensure all submissions comply with ICH, GMP, and radiation-specific regulations • Collaborate with clinical, CMC, and quality teams to align on regulatory requirements • Monitor regulatory landscapes for RLT advancements and update strategies accordingly • Mentor regulatory staff and build capabilities in RLT submissions
Job Requirements
- Bachelor's or advanced degree in regulatory science, pharmacy, or related field
- 10+ years in regulatory affairs, with 5+ years in leadership, focused on biologics or radiopharmaceuticals
- Proven success in IND/CTA filings and interactions with global authorities
- In-depth knowledge of RLT regulations, including dosimetry reporting and orphan drug pathways
- Strong writing and strategic thinking skills, with experience in high-stakes negotiations.
Benefits
- Annual bonus
- Equity participation
- Comprehensive benefits program
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