Interested in Asst. Manager/Manager-Regulatory Affairs job | Apply @ Intas

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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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