Regulatory Affairs Manager — FDA Submissions & Compliance

Job description

Viatris in Washington, DC, seeks a Manager, Regulatory Affairs to lead regulatory submissions (IND, NDA, ANDA) and ensure FDA compliance across development, manufacturing and QA. You will coordinate with QA, QC, Manufacturing, R&D and other groups to assemble documentation and respond to agency requests.

The role requires a Bachelor's degree and 4–7 years of experience, strong written and spoken English, and the ability to navigate guidance documents, prepare amendments, and present findings to

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Worksite address

washington, DC, 20022, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.