Regulatory CMC Manager supporting multi-product global regulatory CMC for products at Marketing Authorisation Application Stage. Focused on documentation preparation, submissions, and providing regulatory support.
Responsibilities
Support the execution of multi-product global regulatory CMC for products at Marketing Authorisation Application Stage
Contribute to the preparation and submission of regulatory CMC documentation
Provide regulatory support to various cross-functional teams
Contribute to strategic Regulatory CMC discussions
Requirements
Experienced CMC Regulatory Manager
Authoring of CMC sections for Marketing Authorisations dossiers
Reviewing CMC sections of regulatory submissions
Working with regulatory colleagues in development of global regulatory CMC strategies and submissions
Participating on cross-functional teams and serving as the primary regulatory CMC contact for assigned products and projects
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