Senior Manager, CMC Regulatory Affairs (Biologics)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, CMC Regulatory Affairs (Biologics) based in the United States.

This role offers a high-impact opportunity to lead global CMC regulatory strategy for complex biologic products across late-stage development, commercialization, and lifecycle management. The position sits at the core of cross-functional biologics development, ensuring alignment between regulatory requirements and technical execution across manufacturing, quality, and analytical functions. It involves shaping and executing regulatory strategies that support late-stage clinical programs, marketing applications, and post-approval changes across global markets. The role requires close collaboration with technical operations and development teams to ensure robust control strategies, comparability assessments, and regulatory compliance. Acting as a key regulatory leader, the individual will also engage directly with health authorities on CMC matters. This is a strategic role with significant influence on product approvals and global patient access in rare disease therapeutics.

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, CMC Regulatory Affairs (Biologics) based in the United States.

This role offers a high-impact opportunity to lead global CMC regulatory strategy for complex biologic products across late-stage development, commercialization, and lifecycle management. The position sits at the core of cross-functional biologics development, ensuring alignment between regulatory requirements and technical execution across manufacturing, quality, and analytical functions. It involves shaping and executing regulatory strategies that support late-stage clinical programs, marketing applications, and post-approval changes across global markets. The role requires close collaboration with technical operations and development teams to ensure robust control strategies, comparability assessments, and regulatory compliance. Acting as a key regulatory leader, the individual will also engage directly with health authorities on CMC matters. This is a strategic role with significant influence on product approvals and global patient access in rare disease therapeutics.

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

 Why Apply Through Jobgether? 

 

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

 

 

#LI-CL1