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Regulatory Affairs Associate (Remote)

Company

Gardner Resources Consulting, LLC
Address Princeton, NJ, United States
Employment type CONTRACTOR
Salary
Category Pharmaceutical Manufacturing
Expires 2023-07-28
Posted at 10 months ago
Job Description

Our Big Pharma client is currently seeking a Regulatory Affairs Associate to assist with Regulatory submissions and a variety of ad hoc projects within Regulatory.


The Regulatory Affairs Associate will help to review documents for Regulatory submissions and will help coordinate documents. The Regulatory Affairs Associate will also obtain documents/information for regulatory submissions from various functional areas and checks for errors, missing information, legibility, translations, etc.


Qualified applicants will have the following expertise:


• Experience with submission work in VaultRim

• Experience with RA compliance reports including (NDA, BLA, ODD, DSUR, PBRER annual reports)