Senior Scientist, Regulatory Affairs - Chemistry Manufacturing & Controls (CMC)

USA - New Jersey - Florham Parkonsitesenior

Posted 3 days ago · via Workday

About this role

Job Description The Position The Senior Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products in accordance with global regulations, guidances and defined regulatory strategies. The Senior Scientist is responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Responsibilities Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.…

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1

Skills match

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2

Level fit

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3

Domain experience

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4

Recency

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5

Location fit

This role is based in USA - New Jersey - Florham Park. We weight your proximity and willingness to relocate.

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