About this role

Lead CMC regulatory strategy for biologics and cell and gene therapy products
Guide CMC comparability, potency strategy, analytical characterization, process development, and control-strategy expectations
Develop global regulatory strategies addressing ATMP requirements
Advise cross-functional teams on evolving CGT regulatory frameworks
Provide expert regulatory guidance on non-clinical development
Ensure non-clinical strategies align with global agency requirements
Represent programs in global health authority interactions
Lead preparation of IND/CTA submissions, IMPDs, BLA/NDA/MAA content

Advanced degree (PhD, PharmD, MS) in life sciences, chemistry, bioengineering, or related field
12+ years of experience in Regulatory Affairs
Extensive leadership in CMC regulatory strategy
Direct experience in cell and gene therapy regulatory development
Deep understanding of non-clinical regulatory requirements
Experience with medical device/combination product pathways
Proven track record developing regulatory strategies for high-complexity programs.

Senior Director, Regulatory & Scientific Affairs

Key skills