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Regulatory Affairs Manager
3 weeks ago
**Description**:
- Represent the company as a competent and reliable partner to the SFDA/ GCC Executive Office in all regulatory matters.
2. Provide the required regulatory activities, information and services that support regulatory approvals in Saudi Arabia/ GCC.
3. Work on building and maintaining strong business relationship with the SFDA/ GCC Executive Office.
4. Ensure the appropriate preparation of the registration files based on SFDA / GCC regulatory guidelines and ensure close follow up to the regulatory submissions.
5. Coordinate new products pricing submissions to the SFDA.
6. Ensure and provide the necessary regulatory activities for maintenance of the existing portfolio (variations, renewals, pricing and new prescribing information updates).
7. Provide the updated registration status to different departments.
8. Align and communicate new product registration plans and registration status to management colleagues.
9. Provide regulatory intelligence concerning current, emerging and changing regulations which might impact the drug development and filing of new products.
10. Provide monthly reports of the registration activities.
11. Identify major regulatory, clinical, technical or operational issues that might impact the successful product filing, approvals, variations and maintenance and propose possible solutions.
12. Build an efficient regulatory network with SFDA/ GCC Executive Office and local industry organizations.
13. Provide leadership, coaching and support to the Regulatory Affairs team.
**Required Experience**:
Will be added soon...
