Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Join Regeneron Pharmaceuticals as an Associate Director, CMC Regulatory Affairs (Hematology/Oncology) in Warren, Worcester County. This full-time position offers the opportunity to lead global regulatory strategies for our hematology and oncology portfolios while mentoring a skilled regulatory team and engaging with FDA and international health authorities.

About the Role

In this Associate Director position, you'll take ownership of CMC regulatory strategy and operations for our hematology and oncology portfolios. This role combines strategic leadership with hands-on regulatory expertise, positioning you as a key voice in how we bring critical medicines to patients who need them most.

What You'll Do

• Develop and implement comprehensive CMC regulatory strategies that support product development, regulatory submissions, and commercialization across all development stages
• Direct and mentor CMC Regulatory Affairs team members, fostering their professional growth and technical excellence
• Coordinate regulatory activities with R&D, Manufacturing, Quality, and Business Development to ensure compliance and strategic alignment
• Engage directly with regulatory authorities including the FDA on CMC-related matters, submissions, and compliance inquiries
• Oversee regulatory intelligence and monitoring to inform strategy and maintain awareness of evolving global CMC requirements
• Support external partners and cross-functional teams in regulatory execution and problem-solving
• Ensure all regulatory submissions and documentation meet quality standards and regulatory expectations

What We're Looking For

• Advanced degree (MS/PhD preferred) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
• Extensive experience in CMC regulatory affairs, with demonstrated expertise in hematology and/or oncology
• Proven track record leading regulatory strategies through development and commercialization
• Strong knowledge of FDA regulations, guidance documents, and global CMC regulatory requirements
• Leadership experience managing and developing regulatory teams
• Excellent communication and stakeholder management skills for interactions with regulatory authorities and internal partners
• Ability to influence and drive alignment across complex, cross-functional environments

About Regeneron Pharmaceuticals

Regeneron is a leading science-based biotechnology company focused on discovering, developing, and commercializing medicines for serious diseases. Our commitment to research, innovation, and patient impact spans oncology, hematology, cardiovascular disease, inflammation, and other therapeutic areas.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.