Regulatory Affairs Manager

Cobel Darou

  • Full Time

  • Tehran

      -   Tehran

Regulatory Affairs Manager

Posted 4 Month ago

Job Description

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. Data remediation. 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.

Requirements

- 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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