Director, Regulatory Affairs - CMC

We are seeking a Director in CMC Regulatory Affairs to provide expert knowledge on small and large molecules within our Global Regulatory Affairs, CMC team. The position involves managing regulatory CMC submission documents, facilitating submission approvals, and developing regulatory strategies. The role is based in the US and is available as a remote position.

Requirements

• Serve as a technical expert in development, testing and manufacturing of Biologics
• Effectively manage the preparation of regulatory CMC submission documents
• Facilitate submission approvals and amendments
• Actively anticipate and develop initial or alternative regulatory strategies
• Provide clients with strategic advice
• Monitor for new regulatory requirements
• Lead and/or participate in the preparation of quotations for projects
• Serve as US Agent for client submissions
• Support right from preclinical to post approval activities for client submissions

Benefits

• Annual leave entitlements
• Health insurance
• Competitive retirement planning
• Employee Assistance Programme
• Life assurance
• Flexible country-specific optional benefits