Job opportunity as Regulatory Affairs Associate at Endo India-Apply before 30th April 2024

Endo India

Website Endo India

About Endo India

Endo India Par Formulations is a pharmaceutical company dedicated to the development, manufacturing, and marketing of safe, innovative, and cost-effective pharmaceuticals aimed at enhancing patient quality of life. Our commitment to ethical standards, coupled with investments in state-of-the-art equipment and facilities, enables us to offer a growing portfolio of products. Joining Endo means embarking on a career where productivity is valued and long-term potential is nurtured.

Post: Regulatory Affairs Associate (Mumbai)

Job Description:

  • Daily Monitoring: Regularly monitor the Drugs@fda site for RLD labeling revisions, ensuring all under review and approved products have up-to-date labeling. Implement necessary changes commercially.
  • Data Management: Manage NDC database, distribute Medication Guide/PIS’s, update Daily Med, and identify revisions for Annual Reportable Changes.
  • Communication: Coordinate with cross-functional teams and vendors for artwork and print proof approval, ensuring compliance with dimensions.
  • Error-Free Labeling: Ensure commercial labeling is free from medication errors.
  • Regulatory Compliance: Stay updated on agency’s new guidance that may impact current and future ANDAs. Review and implement knowledge gained from SBIA Webinars and REDL Guidance’s.
  • SOPs and Documentation: Prepare, review, and revise departmental Standard Operating Procedures. Maintain Radius submissions, ANDA & API track sheets using Excel. Review and prepare new and commercial ANDA labeling components in line with FDA Guidance.
  • Artwork Review: Prepare documents related to artwork review and approval, sharing them with other departments.

Candidate Profile:

  • Qualification: B.Pharm / M.Pharm / MSc with a minimum of one year of relevant experience.

Additional Information:

  • Experience: 1 year
  • Qualification: B.Pharm/ M. Pharm/
  • Location: Digha – West Bengal
  • Industry Type: Pharma/ Healthcare/ Clinical research
  • Functional Area: Regulatory Affairs
  • End Date: 30th April 2024

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