Global Regulatory Head

Actithera; Cambridge (MA); On-site; USD 150,000 - 275,000; Full time

Job summary

Actithera is seeking a Global Regulatory Head to direct regulatory strategy and submissions for the radiopharmaceutical portfolio. The role links clinical development with health authorities and requires expertise across international regulators and dosimetry reporting.

The position leads briefing books, IND/CTA management, and regulatory planning, reporting to the CMO or VP of Regulatory Affairs, with a focus on high-stakes negotiations and team leadership.

Qualifications

• 10+ years in regulatory affairs with leadership experience.
• Experience with IND/CTA filings and global health authority interactions.
• Deep knowledge of radiopharmaceutical regulations and dosimetry reporting.
• Strong strategic writing and negotiation skills.
• Bachelor's or advanced degree in regulatory science, pharmacy, or related field.

Responsibilities

• Lead briefing books creation for regulatory meetings (FDA/EMA).
• Oversee IND/CTA filings including CMC for radionuclides.
• Develop global regulatory strategy, including accelerated programs.
• Represent company in interactions with FDA, EMA, PMDA.
• Ensure compliance with ICH, GMP, and radiation-specific regulations.
• Collaborate with clinical, CMC, and quality teams.
• Monitor regulatory landscapes and update plans.
• Mentor regulatory staff and build team capabilities.

Skills

Regulatory leadership

Global regulatory strategy

IND/CTA submissions

Radiopharmaceuticals knowledge

Strategic writing

Education

Bachelor's or advanced degree in regulatory science/pharmacy or related field

Job description

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.