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Regulatory Associate

Company: PDI, lnc
Location: Woodcliff Lake
Posted on: September 16, 2021

Job Description:

A client located in Woodcliff Lake, NJ is seeking a Regulatory Associate to join their team. This person will be joining a team of 2 other regulatory associates and will responsible for creating, writing, and authoring all regulatory submissions to the FDA specific to pharma products. This person will be submitting NDAs and INDs to the FDA and will not be responsible for the publishing as that is outsourced. This person will be heavily involved in the overall regulatory strategy and will be working cr0ss functionally with quality, R&D, and clinical operations.

-Medical device submission experience

-Experience creating submissions for Canada
-3+ years exp reviewing and writing submissions for FDA regulated products

- Experience with IND, NDA (branded drugs) and/or ANDA (generic drugs); or supplemental submissions to the FDA for drug products (CBE0, CBE30, PAS)

-Experience working cross functionally with R&D, Quality, and Clinical Operations to gather data

-Bachelors Degree is required

Keywords: PDI, lnc, Tenafly , Regulatory Associate, Other , Woodcliff Lake, New Jersey

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