FDA Jobs

 

Associate Regulatory Affairs

Knowledge and understanding of FDA guidelines. Able to make compliant submissions to FDA. Review technical documents and include in ANDAs, NDAs, Supplements and...

Regulatory Associate

Complete cover letters, FDA Form 1571 and other documentation for submission to FDA as needed. Establish contact with the FDA as required to support...

Documentation Specialist

Knowledge of FDA regulations including cGMP’s and current industry practice is desired. Established and growing pharmaceutical manufacturing firm is seeking to...

Regulatory CMC Associate Director - Biologics

Coordinate and lead FDA interactions and negotiations and support global Health Authority interactions for CMC topics....

Drug Safety Associate

Enter ICSRs/MDRs into the Drug Safety database and/or FDA database. Drug Safety Associate Job in Monroe, NJ area....

Regulatory Affairs Associate

Working knowledge of FDA Quality System Regulation (21 CFR 820) & ISO 13485. Regulatory Affairs Associate Job in Parsippany, NJ....

Remote - SAS Programmer

Job Summary Title: SAS Programmer Company: CRO Location: Remote (Headquarters in Canada and New Jersey) Type: Permanent Role Notes: No Corp to Corp ...

Principal Scientist, Upstream Biologics Manufacturing

Other Locations:US- NJ- Summit West Description Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live...

REGULATORY AFFAIRS SPECIALIST

Experience with FDA and related regulatory disciplines highly desirable. Our client, a global developer of quality consumer products that enhance quality health...

Regulatory Affairs Associate

Knowledge of FDA Regulations and ANDA submission required. We are currently searching for a skilled professional to join a well-known client’s team as...

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