Sr Director, Regulatory Affairs CMC *PC

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.

• 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.?

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 Regulatory Affairs within biotechnology and/or pharmaceutical environments.?
• Proven experience supporting global regulatory submissions and interactions with health authorities, in particular in Europe and US.?
• Deep understanding of biologics, ATMPs, Cell & Gene Therapy products and global regulatory frameworks.?
• Excellent communication, leadership and project management skills.?
• Fluent English written and verbal communication skills.?
• Candidates should possess substantial regulatory affairs strategy and submissions experience in one or more of the following areas:? Cell therapies? Gene therapies? Viral vectors? Advanced Therapy Medicinal Products (ATMPs)? Biological product development and Manufacturing?

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk or hear.

The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Generally, this job is performed in an office environment.

The hiring range for this position is expected to fall…