Associate Director Regulatory Affairs

We’re currently working with a global regulatory consulting organisation to hire an Associate Director – Regulatory Affairs CMC. This role will support pharmaceutical and biotech clients with CMC regulatory strategy across development and lifecycle programs.

Key Responsibilities

• Lead CMC regulatory activities across product development and lifecycle management.
• Author and review CMC regulatory documentation and CTD Module 3 for global submissions (IND/IMPD/CTA/NDA/BLA/MAA).
• Support CMC regulatory strategy, Health Authority interactions, and post-approval change management.
• Act as a client-facing regulatory expert working with cross-functional teams.

Requirements

• 9–12 years’ experience (Senior Manager) or 12–15 years’ experience (Associate Director) in CMC Regulatory Affairs.
• Strong experience supporting CMC development and regulatory submissions.
• Knowledge of EU and/or US CMC regulatory requirements and ICH guidelines.
• Degree in a scientific discipline

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