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 sections of regulatory documentation for vaccines, oncology, and rare diseases.
Domain
Biopharmaceuticals / Regulatory Affairs / CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory strategy development, DMF/ASMF submission expertise, CTD format knowledge, regulatory risk identification, change control evaluation, interpretation of domestic and international regulatory guidance
Preferred skills
Molecular Biology/Pharmaceutics/Chemistry background, biologics-focused regulatory CMC experience, manufacturing and/or analytical focus
Technologies
CTD format, DMF, ASMF
Responsibilities
Lead team to develop/implement effective CMC regulatory strategies for submissions, review documents for submission-readiness, lead Regulatory CMC discussions with health authorities, develop regulatory processes and procedures, provide CMC regulatory expertise to manufacturing and quality teams, lead oversight of multiple programs in various therapeutic areas
Seniority
Executive, strategic leadership & team management
