Regulatory Affairs Associate
Dr. Reddy's Laboratories, Inc. - Bridgewater, NJ

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Please Note: Unless an order has been placed with your agency for this role, we will not accept any calls or other inquiries from recruiters for this position. If a candidate is submitted despite this, we are not bound by any agreement terms and can hire the person as we see fit.

Support Regulatory Affairs personnel in the review and submission of NDA, ANDA, ANDS, amendments, supplements, annual reports, etc., in electronic format.

- Support Regulatory Affairs personnel in the review and submission of NDA, ANDA, ANDS, amendments, supplements, annual reports, etc., in electronic format. - Submission of SPL and knowledge to rectify and correct the SPL as needed if any error messages are received - Keep abreast of the regulations and processes from FDA, and ICH that govern documents for submissions. - Assist with maintaining documentation (filing, scanning, and archiving) as needed - Responsible for maintenance of all Regulatory, and FDA correspondence (distributing via e-mail, filing into respective folders in the Regulatory Drive) on an as needed basis. - Creating and maintaining the status report templates for approved as well as under review products - Work with cross-functional team members as needed to ensure regulatory documents are compliant with current regulations and internal regulatory affairs’ specifications. - CTD/eCTD experience a plus - experience with submissions to Health Canada a plus - Proficiency needed in MS Office Programs (Word, Excel, Adobe Acrobat) - Other duties as assigned

Dr. Reddy's Laboratories, Inc. - 17 months ago - save job - block
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About this company
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Established in 1984, Dr. Reddy’s Laboratories (NYSE: RDY) is an emerging global pharmaceutical company. As a fully integrated...