IPCA hiring in Regulatory Affairs

• 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