Global Regulatory Head

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee the regulatory strategy and submissions for the company's radioligand therapy (RLT) portfolio.

• Take ownership of and compile briefing documents for FDA Type B/C meetings and EMA scientific advice.

• Lead the preparation, submission, and ongoing maintenance of INDs, CTAs, and amendments.

• Develop global regulatory strategies, including expedited pathways for oncology RLT assets.

• Act as the company's representative in discussions with FDA, EMA, PMDA, and other health authorities.

• Prepare responses to inquiries from health authorities regarding RLT topics.

• Ensure that submissions adhere to ICH, GMP, and radiation-specific regulations.

• Collaborate with clinical, CMC, and quality teams to meet regulatory requirements.

• Keep abreast of regulatory developments related to RLT and adjust strategies accordingly.

• Mentor regulatory personnel and enhance capabilities in RLT submissions.

⛳️ Requirements

• A bachelor's or advanced degree in regulatory science, pharmacy, or a related discipline.

• Over 10 years of experience in regulatory affairs.

• More than 5 years in a leadership role.

• Experience with biologics or radiopharmaceuticals is essential.

• Demonstrated success in IND/CTA filings and interactions with global health authorities.

• Comprehensive knowledge of RLT regulations, including dosimetry reporting and orphan drug pathways.

• Excellent writing and strategic thinking abilities.

• Experience in high-stakes negotiations.

• Familiarity with ICH, GMP, and radiation-specific regulations, including 21 CFR Part 212 for PET drugs.

🏝️ Benefits

• Eligibility for annual bonuses.

• Participation in equity programs.

• A comprehensive benefits package.

• Compensation that is market-based and results-driven.