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.
At Viatris, we offer 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
strategic CMC regulatory approaches
CMC submission documentation
product compliance
CMC change control
liaison with regulatory agencies
Nice-to-have
collaborative culture
courage and resilience
sustainable operations
innovative solutions
healthier communities
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
Proven ability to partner successfully with other Regulatory functions