The Director, Regulatory Affairs CMC is an emerging senior level position, recognized as an expert for global CMC regulatory knowledge and quality expertise
Job Summary
The Director, Regulatory Affairs CMC is an emerging senior level position, recognized as an expert for global CMC regulatory knowledge and quality expertise.
Ensures all CMC regulatory activities are executed effectively & efficiently, and in compliance with external regulatory requirements & internal quality procedures.
Viatris offers competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Matching Summary
The Director, Regulatory Affairs CMC is an emerging senior level position, recognized as an expert for global CMC regulatory knowledge and quality expertise.
Skills & Requirements
Must-have
global CMC regulatory knowledge
CMC submission documentation
liaison with regulatory agencies
drug development and commercial manufacturing
Nice-to-have
courage and resilience
collaborative culture
making a difference in the world
Key Requirements
Extensive years of mandatory hands-on CMC authoring experience
Extensive years of people and/or project management experience
High level of knowledge of development & commercial activities and cGMP’s
Advanced understanding of current and emerging regulatory requirements