Principal Scientist (Director) - Regulatory Affairs-CMC
Core
Developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises, leading the preparation and submission of CMC sections for commercial or new biologics products.
Role type
Principal Scientist / Director, Regulatory CMC
Builds
Global regulatory submissions (INDs, BLAs, post-approval changes) for biologics products
Domain
Biologics / Pharmaceutical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory strategy development, global guideline application (IND/BLA/post-approval), risk mitigation for complex products, regulatory milestone delivery, cross-functional collaboration, product in-license/divestment/withdrawal support, new technology development support, mentoring junior scientists
Preferred skills
ADC regulatory CMC experience
Technologies
None explicitly listed
Responsibilities
Lead CMC Regulatory Strategy Document development, execute detailed global regulatory submissions, manage CMC documentation lifecycle, resolve complex project issues with cross-functional partners, provide leadership in product due diligence and withdrawal, mentor team members
Seniority
Principal / Director, strategic leadership with hands-on execution
