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