Executive Director, CMC Regulatory Science
Core
Lead a team of CMC experts to prepare and oversee CMC and Quality regulatory applications and agency correspondence for a portfolio of products.
Role type
Executive Director, CMC Regulatory Science
Builds
Regulatory submissions (IND/CTA/BLA/MAA) and CMC strategies for vaccines, oncology, and rare diseases.
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
CMC regulatory strategy, DMF/ASMF submissions, CTD format, US/EU/ROW regulations, manufacturing/quality change controls, team leadership
Preferred skills
Molecular Biology/Pharmaceutics/Chemistry background, biologics-focused regulatory CMC, manufacturing/analytical focus
Technologies
CTD, DMF, ASMF
Responsibilities
Lead team to develop/implement CMC regulatory strategies; Review documents for submission-readiness; Lead Regulatory CMC discussions with health authorities; Develop regulatory processes and procedures; Provide CMC expertise to manufacturing and quality teams; Lead oversight of multiple programs in various therapeutic areas
Seniority
Executive, hands-on IC with strategic oversight