Global Regulatory Lead, Radiopharmaceuticals

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

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.