Senior Manager​/Associate Director Regulatory CMC

Senior Manager/Associate Director, Global Regulatory Affairs CMC About the Opportunity

A growing biotechnology company is seeking an experienced Senior Manager/Associate Director, Global Regulatory Affairs CMC to support regulatory strategy and execution across the development and commercialization of innovative biologic therapies.

This individual will play a key role in developing and implementing global CMC regulatory strategies, partnering with cross‑functional teams to support regulatory submissions, health authority interactions, and lifecycle management activities. The ideal candidate will bring strong biologics regulatory expertise and a proven ability to navigate complex regulatory environments while driving successful outcomes across multiple programs.

• Develop and execute global CMC regulatory strategies for development and commercial‑stage products.
• Lead and support global regulatory submissions, including INDs, CTAs, BLAs, MAAs, and other lifecycle management activities.
• Identify regulatory risks and develop mitigation strategies to support program objectives.
• Provide strategic regulatory CMC guidance to cross‑functional teams, including Manufacturing, Quality, Analytical Development, and Process Development.
• Review submission content to ensure compliance with applicable global regulatory requirements and health authority expectations.
• Lead CMC‑related interactions and communications with global regulatory agencies.
• Evaluate manufacturing changes and change controls from a regulatory perspective.
• Support the development and continuous improvement of regulatory processes, procedures, and submission standards.
• Interpret evolving regulatory guidance and advise stakeholders on potential impacts to development and commercial programs.
• Contribute to regulatory planning and execution across multiple programs within a fast‑paced environment.

• BS, MS, or PhD in a scientific discipline such as Chemistry, Chemical Engineering, Molecular Biology, Pharmaceutics, or a related field.
• 8+ years of pharmaceutical or biotechnology industry experience.
• 5+ years of Regulatory Affairs CMC experience supporting biologic products.
• Strong understanding of global CMC regulations and CTD submission requirements.
• Experience supporting regulatory activities throughout product development and commercialization.
• Familiarity with global regulatory submission processes and health authority expectations.
• Ability to effectively collaborate across cross‑functional teams and influence stakeholders.
• Excellent written, verbal, organizational, and project management skills.

• Opportunity to support innovative biologic therapies with meaningful patient impact.
• High visibility role partnering across technical, quality, manufacturing, and regulatory functions.
• Broad exposure across development, registration, and lifecycle management activities.
• Collaborative environment with opportunities for professional growth and leadership.