Senior Director, Regulatory CMC

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

📋 Description

• Provide strategic oversight for global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies throughout radiopharmaceutical development projects and upcoming commercial offerings.

• Develop and implement CMC regulatory strategies, and author and supervise the Module 3 and Quality sections of regulatory filings.

• Lead interactions with health authorities regarding CMC, radiochemistry, and manufacturing processes.

• Collaborate with Manufacturing, Quality, Clinical Development, and Technical Operations to ensure CMC preparedness at all phases of development.

• Offer expert advice on global regulatory standards for CMC, especially concerning radiopharmaceuticals.

• Ensure that CMC documentation is scientifically sound, compliant, and aligned with clinical and manufacturing strategies.

• Lead the regulatory strategy for CMC modifications, comparability assessments, process alterations, site transfers, and manufacturing advancements.

⛳️ Requirements

• A Bachelor’s degree in a scientific field is required; an advanced degree (PhD, MS, or equivalent) in chemistry, pharmaceutical sciences, radiochemistry, or a related area is highly preferred.

• A minimum of 12+ years of progressive experience in Regulatory Affairs, with a strong emphasis on CMC regulatory strategy and submissions.

• Significant hands-on experience in radiopharmaceutical CMC regulatory affairs is essential, including support for radiochemistry, manufacturing controls, and quality strategies for clinical and/or commercial initiatives.

• Experience with alpha-emitting radiopharmaceuticals and peptide-based products is strongly preferred.

• Proven success in leading CMC sections of major global regulatory submissions, including INDs, CTAs/IMPDs, and marketing applications.

• Extensive experience engaging with global regulatory bodies (e.g., FDA, EMA), including leading preparations for and participating in formal meetings (e.g., Type B, Type C).

• Strong experience collaborating cross-functionally with Manufacturing, Technical Operations, and Quality teams.

• Experience in CMC change management, comparability assessments, site transfers, technical transfers, and/or commercialization readiness is highly preferred.

• Experience working with both internal and external manufacturing networks, including CDMOs and contract testing laboratories, is strongly preferred.

🏝️ Benefits

• Remote, home-based position

• Flexibility to support meetings across various time zones

• Opportunities for professional development

• Equal employment opportunities