Associate, Regulatory & QA Operations at Dr. Reddy's Laboratories, Inc. in Princeton, New Jersey

Posted in Other 27 days ago.

Job Description:


Position at Dr. Reddy's Laboratories, Inc.

By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference fortheircommunity andeverycommunity.

We have an opening for an Associate, Regulatory & QA Operations in our Princeton, NJ office.

This positionwill be responsiblefor:

  • Daily regulatory submissions to FDA and Health Canada through the Electronic submission gateway.

  • Archival and maintenance of all regulatory documentation including any physical paper correspondences and electronic folders.

  • Coordinateofpromotional review activities

  • Manage Puerto Rico licensing activities

  • Support and manage state licensing documentation, DEA documentation

  • Daily reports on submissions to Regulatory agencies

  • CoordinateCoPPfiling andregistrationsto facilitate regulatory filings in ROW countries

  • Dissemination of any regulatory documentation received through physical media

  • Invoice Processing & vendor payments managementincluding invoices from regulatory agency.

  • Administrative support toQA andRA team and Head of SCM.

  • Support and manage state licensing documentation, DEA documentation

  • Support / coordinate for compiling or mailing samples, documents, CDs to regulatory agencies.

  • Onsite andOffsite archival and retrieval of documents as needed.

  • Coordinate training / registrations and departmental memberships /registration with various professional entities like USP, AAM,SBIA

  • Litigation documentation support to IP

  • Any additional responsibilities as assigned by hiring manager.

Education & Experience:

  • 1 to 3 years of experience in Regulatory and QA operations

  • Associate degree / degree in any discipline with basis computer skills.

  • Basic understanding of Documentation Control and Document Management electronic systems.

Equal Opportunity Employer: Minorities/Women/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.