Experience spanning three decades in healthcare, with a wide range of formulations to meet the needs of ailing humanity, Intas Pharmaceuticals headquartered at Ahmedabad (India), is now a force to reckon with, in the global pharma horizon. With expertise in a range of formulations, from tablets to injectables to newer drug delivery systems, Intas is currently ranked 17th among the Indian Pharma majors.
Position : Asst. Manager/Manager – Regulatory Affairs
No of Post : 1
Duration : 5 – 7 years
Location : Ahmedabad
Desired Profile : B.Pharma – Pharmacy | M.Pharma – Pharmacy
Job Description :
- Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.g., ACTD dossiers, variations, safety reports and PSURs) in accordance with applicable regulations
- Interface with external regulatory groups (partner, consultants, etc.) in the preparation /review/ compilation/ finalization/ submission/ posting of regulatory submissions.
- Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.).
- Review and communicate current & emerging regulatory requirements.
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