- Skills: Good Manufacturing Practice (GMP), HAZOP Study, and other regulatory and pharmaceutical manufacturing skills.
Key Responsibilities
- Submission Activities:
- Handle submission-related activities for the European market.
- Support contract manufacturing projects by ensuring regulatory compliance.
- 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).
- Coordination with R&D:
- Work closely with the Research & Development (R&D) and Analytical Development departments to finalize technical documents and specifications.
- Product Dossiers:
- Compile product dossiers required for regulatory submissions.
- Query Responses:
- Respond to regulatory agencies’ queries to facilitate product approval processes.
- Application Review:
- Review post-approval variation applications prepared by subordinates to ensure they are adequate and correct.
- Database Maintenance:
- Maintain databases to keep track of submissions, grants, and approvals.
- Site Transfer Monitoring:
- Oversee site transfer activities and ensure timely submission of documentation and approval.
- Technical Support:
- Provide technical support to marketing managers regarding regulatory affairs.
- Regulatory Updates:
- Stay updated with current regulatory guidelines and ensure all activities comply with these regulations.
