Senior Manager (Level 1), Regulatory Affairs CMC
Core
Lead regulatory affairs projects for human and veterinary medicinal products, medical devices, and supplements, focusing on CMC aspects and marketing authorization.
Role type
Senior Manager, Regulatory Affairs CMC
Builds
Regulatory submissions and marketing authorizations for pharma and medtech clients
Domain
Life Sciences / Regulatory Affairs / CMC
Deliverable
client delivery
Required skills
CMC regulatory strategy, project management, client relationship management, team leadership, regulatory intelligence, scientific advice procedures, process optimization, commercial proposal support
Preferred skills
Certification in clinical research or regulatory affairs, change management expertise
Technologies
Regulatory submission frameworks, project management tools
Responsibilities
Develop and maintain client relationships; prepare and review CMC documents for regulatory submissions; coordinate project teams and external partners; provide consultancy on CMC services; present seminars to clients and colleagues; oversee project delivery to budget; support commercial and business development activities
Seniority
Senior, hands-on IC with management responsibilities
