全球监管负责人

Global Regulatory Head
Position Summary
The Global Regulatory Head directs the regulatory strategy and submissions for the company's RLT portfolio, ensuring compliance with international standards for radiopharmaceuticals. This strategic role owns briefing books, IND/CTAs/amendments, and overall regulatory planning to facilitate timely approvals. Reporting to the CMO or VP of Regulatory Affairs, it requires deep knowledge of global regulations for radioactive drugs, bridging clinical development with health authorities.

Key Responsibilities
Briefing Books Ownership: Author and compile briefing books for regulatory meetings (e.g., FDA Type B/C, EMA scientific advice), incorporating RLT data on safety, efficacy, and manufacturing.
IND/CTA/Amendments Management: Lead the preparation, submission, and maintenance of INDs, CTAs, and amendments, addressing RLT-specific elements like CMC for radionuclides and dosimetry justifications.
Regulatory Strategy Development: Formulate global regulatory strategies, including accelerated pathways (e.g., Breakthrough Therapy Designation) for RLT assets in oncology.
Health Authority Interactions: Represent the company in interactions with FDA, EMA, PMDA, and other agencies, preparing responses to queries on RLT topics.
Compliance Oversight: Ensure all submissions comply with ICH, GMP, and radiation-specific regulations (e.g., 21 CFR Part 212 for PET drugs).
Cross-Functional Integration: Collaborate with clinical, CMC, and quality teams to align on regulatory requirements.
Intelligence and Planning: Monitor regulatory landscapes for RLT advancements and update strategies accordingly.
Team Leadership: Mentor regulatory staff and build capabilities in RLT submissions.
Qualifications

• 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.

Compensation
Actithera offers a competitive compensation package designed to reward both performance and expertise through market-based, results-driven pay.
For this role, the anticipated base salary range is $150,000 – $275,000, complemented by eligibility for an annual bonus, equity participation, and a comprehensive benefits program.
Your actual salary will be determined based on the scope of the role and your unique experience and capabilities—because we know great contributions come from great people.
Actithera is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.
Salary: $150,000-$275,000Originally posted on Himalayas