Regulatory Affairs CMC Manager
Core
End-to-end responsibility for Module 3/CMC new product development and life cycle management, acting as the regulatory CMC lead for strategy and deployment.
Role type
Senior Regulatory Affairs CMC Manager
Builds
CTD Module 3/CMC documentation for marketing authorization applications and variations globally
Domain
Pharmaceuticals / Medical Devices
Deliverable
client delivery
Required skills
Regulatory strategy development, Module 3/CMC maintenance, cross-functional technical leadership, project management, people management
Preferred skills
Expertise in medicinal products and medical devices regulatory classifications, global regulatory framework knowledge
Technologies
CTD documentation
Responsibilities
Lead a team of regulatory affairs CMC product owners, provide technical expertise to R&D partners, represent the function in regulatory and cross-functional teams, create an environment of operational excellence
Seniority
Senior, hands-on IC with team leadership
