Cobel Darou on behalf of one of multi-national companies hires:
1. Coordination with Unit Head/Director of RA Function for compilation and filing of registration dossiers as per requirements of Iran Ministry of Health.
2. Good knowledge of CTD/I-CTD dossier requirements
3. Maintenance of valid Drug registration licenses of registered products as per local laws
4. Coordinate with Unit Head/Director of RA Function and manage compilation and filings of NDAs/MAT/MAH transfers and CMC variations.
5. Consistent performer who delivers with diligence and sense of urgency and ensures company ethics and ABAC policies.
6. Coordination with Head/Director of RA Function and filing of updated labelling to Iran MoH
7. Regular follow-ups with Iran MoH on all regulatory matters/filings.
- Pharmacy /Health Sciences Graduate (preferably with Specialization in Pharmaceutical Regulatory Affairs)
- Minimum 4-5 years of working experience in Regulatory Affairs of Pharmaceuticals.
- Compliance with new Policies and SOPs of Iran MoH.
- Well versed with potential regulatory challenges e.g., supplies shortages, local lab testing issue, Reference standards and analytical dossiers filings for new products.
- Fluent in speaking, reading and writing English
- Can interact effectively
- Good team player
Can't find jobs you're looking for?
Log In/Register for more opportunities!
Cobel Darou is a Leading private pharmaceutical company founded in 2002. Our main activities are registration, importation, manufacturing, distribution and sales & marketing. Our partners are several international pharmaceutical companies which are pioneers in the industry. Our main objective is to acquire the best talent and excel in their development.
500 employees or more
Register for free Use
and speed up job searching