Sr Director, Regulatory Affairs CMC *PC 1626

Your Role

The role will lead the team of global CMC RA managers and as the global regulatory expert for Chemistry, Manufacturing & Controls (CMC) activities supporting our Cell & Gene Therapy (CGT) portfolio.

The role will oversee and provide strategic regulatory leadership across development, registration and lifecycle management while ensuring compliance with global regulatory requirements.

Essential Details and Responsibilities

• Coach mentor and lead global CMC RA manager who will lead global CMC regulatory strategies for Cell & Gene Therapy products throughout development and commercialization as part of the overall global regulatory strategy for each product / compound.
• Oversee and develop strategy and review and approve CMC sections for regulatory submissions including INDs, CTAs, BLAs, MAAs, amendments and post-approval variations.
• Oversee and provide strategic guidance on regulatory requirements related to manufacturing processes, analytical methods, specifications, comparability studies, process validation and control strategies.
• Oversee and assess regulatory impact of manufacturing changes and define appropriate regulatory pathways worldwide.
• Support interactions with global health authorities including FDA, EMA, MHRA and other agencies in collaboration with local RA representatives.
• Collaborate closely with Process Development, Manufacturing, Quality, Supply Chain and Clinical Development functions.
• Monitor regulatory developments and industry trends relevant to advanced therapies and translate them into regulatory strategies.
• Drive regulatory risk assessments and mitigation plans across the product lifecycle.

Requirements

• Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related scientific discipline; +12 years demonstrated hands-on expertise in Chemistry, Manufacturing & Controls (CMC) Regulatory Affairs for Cell & Gene Therapy (CGT) products is mandatory.
• Extensive experience in