Glenmark Pharmaceuticals Limited [Glenmark] is an India-based growing pharmaceutical company headquartered at Mumbai [formerly, Bombay]. Incorporated in 1977, the Company is focused on the manufacture and marketing of formulation products and active pharmaceutical ingredients [API] in India as well as globally and enjoys a diversified and growing presence in regulated and developing international markets. Over the past five years, the Company has also catalyzed its growth through investment in dedicated research and development including cutting-edge New Chemical Entity [NCE] research.

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At Glenmark, our people are encouraged to discover and follow their own unique path of career development.

Aligning individual aspirations to business goals, we offer a range of opportunities that allows our talent to develop both breadth and depth of experience. This includes cross-functional movements, stretch assignments, and international stints.

We recognize high performance & drive for results through fast track career paths & other developmental opportunities. Each team member is supported on their growth journey through continuous learning interventions.

Position: Asst Manager – Regulatory Affairs

Location: Mumbai, Maharashtra

Job Description:

  • The objective of the role is to evaluate post-approval changes for the EU and Canada markets as per regulatory guidelines.

Should have worked on PLCM activities like Variations – Type 1A, 1B, and Type II for EU market + Level 3 & 4s changes for the Canada market. Respond to Health authority deficiencies raised on post-approval submissions.

The main responsibilities include:

  • Evaluation of change control (CC) from RnD as well as manufacturing sites for APIs/Finished Product/Excipients etc
  • Evaluation of reduced testing proposals for APIs/excipients/In-process specifications
  • Review and compilation of documents required for variations for EU and Canada
  • Coordinate with different internal and external stakeholders for the data required for filing of various post-approval variations for EU and Canada
  • Evaluation of proposals related to alternate APIs/excipients/packaging material
  • Evaluate various drug product site transfer proposals and Supplier driven changes assessment for Canada and EU
  • To maintain various post approval databases for EU and Canada and keep them updated at all times
  • Keep updated with various guidelines from Health authorities
  • To prepare and review consolidated dossier for filing RUPs and Duplicate dossier in the EU market

Qualification: B.Pharma/M.Pharma

Experience: 6-10 Years

Salary: 7,00,000 to 10,00,000 INR CTC/PA

Contact Details:

career@glenmarkpharma.com, heena.vasani@glenmarkpharma.com

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