Assistant Manager For Regulatory Affairs (MENA market) Macleods Pharma

Role & responsibilities

1. Ensure timely preparation and submission of registration dossiers, responses to Ministry of Health (MOH) queries, renewal applications, and variation filings for Rest of World (ROW) markets in accordance with predefined timelines.
2. Coordinate and finalize responses to deficiencies or queries raised by regulatory authorities on submitted applications.
3. Review technical documents related to products under development, for filing and commercialization purposes.
4. Evaluate and approve technical documentation received from R&D and manufacturing units.
5. Review initial and updated approval packages to ensure alignment with granted approvals.
6. Maintain lifecycle management activities and ensure proper archival of regulatory documentation in internal databases

Preferred candidate profile

Exp- 10 to 15 yrs experience in Regulatory Affairs- ROW market