About the job
POSITION SUMMARY
Responsible for support to Project Lead for Regulatory Submissions to EU Health Authorities for initial filings, through the assessment cycle till approval of application.
Responsibility
- To maintain project trackers for document collation, review and finalisation
- Interaction with stakeholders for receipt of documents for filing
- Timely evaluation and approval of change controls.
- To prepare approval packages for approved products and provide it to EU QA team as support to commercialization of products.
- Ensure continuous maintenance of databases used by the team.
- Provide regulatory support and co-ordinate with stakeholders such as R&D, Manufacturing Sites, QA, Purchase, Packaging Development etc. for the data required for routine tasks related to regulatory submissions.
Apply through below link
Senior Officer | Glenmark Pharmaceuticals | LinkedIn