Regulatory Consultant – CMC, Small Molecule Products
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Job Description
Support execution of global regulatory CMC strategy and submissions for small molecule products. Collaborate with cross-functional teams at Syneos Health to deliver effective regulatory compliance in the biopharmaceutical industry.
Responsibilities:
- Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on Middle East and North Africa.
- Review CMC sections of regulatory submissions.
- Collaborate with regulatory colleagues in developing global regulatory CMC strategies.
- Act as the primary regulatory CMC contact for assigned products and projects.
Requirements:
- Support the execution of multi-product global regulatory CMC for marketed products for small molecule products.
- Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies for small molecule products.
- Works with regulatory colleagues in development of global regulatory CMC strategies and submissions.
- Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.
Benefits:
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself.
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