Lead Chemistry, Manufacturing and Controls (CMC) regulatory activities across development, registration, and early lifecycle stages.
Develop and implement CMC regulatory strategies for US and global filings and lifecycle maintenance.
Prepare, review and maintain CMC components of regulatory submissions and responses.
Provide clear regulatory advice to cross-functional teams on compliance, risk and readiness for submissions.
Lead agency interactions and act as a primary contact for regulatory authorities when required.
Support inspections, quality events and supply continuity through regulatory strategy and documentation.
Mentor colleagues and contribute to process improvements that raise quality and efficiency.

Bachelor’s degree in life sciences, pharmacy, chemistry, engineering or related field.
Minimum 6 years of CMC regulatory affairs experience in the pharmaceutical, biologics, or combination product space.
Experience preparing and authoring CMC dossier sections for US regulatory submissions.
Practical knowledge of US regulatory requirements, Good Manufacturing Practices, and relevant ICH guidance.
Proven ability to work in cross-functional teams and manage multiple projects to meet deadlines.
Strong written and verbal communication skills with experience communicating technical information clearly.

Senior Regulatory Manager

Key skills