Senior Director, Regulatory Affairs CMC

This is a fully remote position, open to applicants in New Jersey, +4 more states.

📋 Description

• Lead a team of global managers in CMC Regulatory Affairs.

• Act as the global regulatory authority for Chemistry, Manufacturing & Controls activities that support the Cell & Gene Therapy portfolio.

• Provide strategic regulatory leadership throughout development, registration, and lifecycle management.

• Mentor, coach, and guide global CMC Regulatory Affairs managers.

• Direct global CMC regulatory strategies for Cell & Gene Therapy products during development and commercialization phases.

• Oversee the strategy for, review, and approve CMC sections for regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments, and post-approval variations.

• Offer strategic advice on regulatory requirements concerning manufacturing processes, analytical methods, specifications, comparability studies, process validation, and control strategies.

• Evaluate the regulatory impact of manufacturing changes and outline suitable regulatory pathways globally.

• Facilitate interactions with global health authorities, including the FDA, EMA, MHRA, and other agencies.

• Collaborate with departments such as Process Development, Manufacturing, Quality, Supply Chain, and Clinical Development.

• Keep abreast of regulatory developments and industry trends related to advanced therapies and incorporate them into regulatory strategies.

• Lead regulatory risk assessments and develop mitigation plans throughout the product lifecycle.

• Perform responsibilities in an office environment while meeting specified physical demands.

⛳️ Requirements

• Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry, or a related scientific field.

• A minimum of 12 years of proven hands-on experience in Chemistry, Manufacturing & Controls (CMC) Regulatory Affairs for Cell & Gene Therapy (CGT) products is essential.

• Extensive background in Regulatory Affairs within biotechnology and/or pharmaceutical settings.

• Demonstrated experience in supporting global regulatory submissions and engaging with health authorities, particularly in Europe and the US.

• Profound understanding of biologics, Advanced Therapy Medicinal Products (ATMPs), Cell & Gene Therapy products, and global regulatory frameworks.

• Exceptional communication, leadership, and project management abilities.

• Proficient in English, both written and verbal.

• Significant experience in regulatory affairs strategy and submissions related to one or more of the following: cell therapies, gene therapies, viral vectors, ATMPs, biological product development, and manufacturing.

• Capable of managing multiple tasks simultaneously.

• Able to perform the specified physical duties, including occasionally lifting or moving up to 25 pounds.

🏝️ Benefits

• Health insurance

• Vision insurance

• Dental insurance

• 401(k) plan

• Potential for additional compensation, such as bonuses or commissions, for certain roles

• Reasonable accommodations available for candidates and employees with disabilities