Job Description
A Senior Manager in RA CMC plays a central role in shaping and executing regulatory strategy. In this position, you will lead the development of global or regional CMC regulatory plans that balance scientific innovation with clear compliance requirements.
You will oversee the preparation, authoring, review, and submission of CMC documentation for health authorities, including materials for clinical trial applications, marketing authorizations, and post-approval variations.
As the primary point of contact for CMC-related inquiries, you will manage interactions with health authorities, ensure consistency in responses, and guide discussions with accuracy and confidence.
Success in this role requires close partnership with cross-functional teams, including Quality Assurance, Manufacturing, Supply Chain, and Commercial groups.
You will work with these teams to align regulatory strategy, define filing p...