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About Company

This position at Ipca Laboratories Limited as a Regulatory Affairs Executive is ideal for candidates with experience in pharmaceutical manufacturing, particularly in regulatory affairs related to the European market. Here's a detailed overview of the job requirements and responsibilities:

Position Name :

Executive, Regulatory Affairs - Formulation

Organization :



M.Sc. (Master of Science), B.Pharm (Bachelor of Pharmacy), or M.Pharm (Master of Pharmacy).


4 - 8 years and above


11.6 Lakhs per year


West Mumbai

  • Skills: Good Manufacturing Practice (GMP), HAZOP Study, and other regulatory and pharmaceutical manufacturing skills.

Key Responsibilities

  1. Submission Activities:
    • Handle submission-related activities for the European market.
    • Support contract manufacturing projects by ensuring regulatory compliance.
  2. Liaison Work:
    • Communicate with customers regarding their product licenses and implement necessary changes at the manufacturing site.
    • Coordinate with stakeholders to gather and review technical documents for accuracy for EU submissions and customer Marketing Authorizations (MAs).
  3. Coordination with R&D:
    • Work closely with the Research & Development (R&D) and Analytical Development departments to finalize technical documents and specifications.
  4. Product Dossiers:
    • Compile product dossiers required for regulatory submissions.
  5. Query Responses:
    • Respond to regulatory agencies’ queries to facilitate product approval processes.
  6. Application Review:
    • Review post-approval variation applications prepared by subordinates to ensure they are adequate and correct.
  7. Database Maintenance:
    • Maintain databases to keep track of submissions, grants, and approvals.
  8. Site Transfer Monitoring:
    • Oversee site transfer activities and ensure timely submission of documentation and approval.
  9. Technical Support:
    • Provide technical support to marketing managers regarding regulatory affairs.
  10. Regulatory Updates:
    • Stay updated with current regulatory guidelines and ensure all activities comply with these regulations.

Application Link

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