Director Regulatory CMC
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Career Opportunity
We are seeking a highly skilled and experienced Director Regulatory CMC to join our team. As a key member of our regulatory affairs department, you will be responsible for developing and implementing effective regulatory strategies across global markets.
This is an exciting opportunity for a talented professional who thrives in a fast-paced environment and is passionate about driving results through strategic thinking and collaboration.
* The successful candidate will have extensive technical knowledge in the preparation and analysis of global CMC submission documentation.
* Possess strong written and oral communication skills with ability to engage effectively with cross-functional teams.
* Demonstrated experience serving as subject matter expert in specific relevant disciplines or as recognized resource for specialized projects.
About Your Skills & Experience:
To succeed in this role, you should have a combination of hands-on CMC authoring experience, high level knowledge of development & commercial activities, cGMP's, advanced understanding of current emerging regulatory requirements expectations criteria for submission approval globally.
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