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
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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.
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