Regulatory Affairs Manager – CMC

About the role

This role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in line with global regulations and guidance. It also involves preparing and reviewing information required for the development of regulatory CMC dossiers for commercial products.

Key responsibilities

• Provide input to global product and project regulatory strategies by assessing CMC changes, identifying requirements and evaluating supporting documentation.
• Lead the development, authoring and review of CMC submission components for post‑approval supplements, annual reports, registration renewals and health authority queries.
• Liaise with global CMC, manufacturing divisions and external partners to ensure compliant change management.
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Deliver regulatory milestones across the product lifecycle and flag issues to CMC management.

Required profile

• Bachelor’s degree in Science, Engineering, Pharmacy, Chemistry, Biology or related field (advanced degree preferred).
• 5–7 years of pharmaceutical industry experience, including at least 4 years managing CMC regulatory submissions for small molecules, vaccines or biologics.
• Ability to travel to CMO sites as needed.

Required skills

• Electronic Common Technical Document (eCTD) preparation.
• Experience with GMP electronic document systems.
• Knowledge of pharmaceutical manufacturing, analytical testing and quality assurance.
• Documentation review and change‑control expertise.