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.
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.