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Regulatory Affairs, CMC Consultant
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- In this role, you will be responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of our pipeline compounds and products.
- Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of investigational products.
- Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions, including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.
- Serve as the CMC regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are adequately met.
- An advanced degree (MSc or PhD) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field is desired.
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