Regulatory Manager, Delivery – CMC RA
Core
Lead and coordinate delivery of CMC (Chemistry, Manufacturing and Controls) regulatory activities to support timely submissions and lifecycle management of vaccines.
Role type
Senior Regulatory Manager, CMC RA
Builds
Regulatory dossiers (CTD Module 3) and post-approval variation documentation for vaccines.
Domain
Pharmaceuticals / Biotechnology / Vaccines
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory affairs, CTD Module 3 authoring, post-approval variation management, cross-functional coordination, project timeline tracking, health authority interaction, subject matter expertise, process improvement
Preferred skills
Global vaccine submissions, EU and US regulatory processes, change control, GMP interfaces, regulatory document management systems, digital transformation
Technologies
Regulatory document management systems, regulatory information tools
Responsibilities
Lead planning and delivery of complex CMC submissions and post-approval changes; Manage multiple variation projects for Finished Products, Intermediates, and Active Pharmaceutical Ingredients; Coordinate cross-functional inputs to create submission-ready documentation; Track project timelines and implement risk mitigation; Respond to health authority questions and support regulatory negotiations; Serve as SME mentoring team members and driving process improvements
Seniority
Senior, hands-on IC with mentorship
