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Manager - Regulatory Affairs - United States  

Dr.Reddy's (company)

Posted on : 02 May 2017

Project Description


At Dr. Reddy’s, a global pharmaceutical company, 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 for their community and every community.

This corporate position is responsible for the preparation, review and submission of all types of regulatory filings with US FDA (DMF/ ANDA /505b2/ IND/Supplements) to support the Dr. Reddy’s North American Generic (NAG) business in Princeton, NJ.


  • ·         Assist Regulatory team leader in reviewing all pre-filing and preapproval documents to ensure compliance with current regulations from US FDA (mandatory).  This review includes a detailed scientific/regulatory review ensuring compliance with all appropriate regulations.  Communicate significant and/or potential issues to Regulatory team leader.
  • ·         Provide regulatory recommendations for transdermal, MDI, nasal, soft gel, and topical dosage forms
  • ·         Prepare regulatory / submission strategies for assigned projects.
  • ·         Provide need based regulatory support to PSAI business.
  • ·         Evaluate change controls and post approval filings for assigned projects.
  • ·         Create and maintain a regulatory document control with appropriate distribution of regulatory documents.
  • ·         Provide regulatory support for drug import/export activities as well as for facility registrations, renewals, and ensuring GDUFA related submissions.
  • ·         Provide need based interaction with FDA and consultants.
  • ·         Support Marketing, Contracts, QA, PV and Supply Chain Management teams with customer queries and custom clearances.

  • ·         Must have a BS (MS is a plus) in a scientific discipline (Chemistry preferred) with at least 5 years of Regulatory Experience in the pharmaceutical industry.
  • ·         Experience in generic pharmaceutical with transdermal, MDI, nasal, soft gel, and topical dosage forms a plus.
  • ·         Knowledge of FDA, GMP, & CMC Regulatory requirements
  • ·         Position requires attention to detail and ability to work as a team player interacting with multiple internal and external diverse cultural groups.
  • ·         Good communication (verbal & written), interpersonal, and computer (MS Office Suite) skills required.

**We are a corporate office and not a doctor’s office. Unsolicited resumes sent to our office will not be considered for any open positions. Only interested parties that apply through our Career website will be considered for positions within Dr. Reddy's Laboratories, Inc.**

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.

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.