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38 Dossier Jobs

Manager-India Regulatory Affairs

5-10 years

Vadodara

1 vacancy

Manager-India Regulatory Affairs

Sun Pharmaceutical Industries

posted 2d ago

Job Role Insights

Job Description

Hi,

We are having an opening for Manager-IRA at our Baroda location.


Job Summary : Regulatory submissions of drugs in India.


Area of Responsibility :

  • Evaluation of regulatory strategies for products to be registered in India.
  • Evaluation and submission of application on online portal for getting bioequivalence study / clinical trial permission / licence to import drug for these studies from DCGI.
  • Evaluation and submission of application on online portal for getting domestic manufacturing and marketing permission from DCGI.
  • Evaluation and submission of application on online portal for NCE molecules.
  • Evaluation and submission of application on online portal for global clinical trial applications.
  • Evaluation of the CMC documents/CT-BE documents and other documents that need to be submitted with the applications and coordinating with the respective team for finalization.
  • To do literature search, to make rationale for products to be filed to DCGI.
  • Reviewing Draft Gazette notification related to regulatory domain and sharing comments on the same.
  • Submission of samples to IPC for testing as part of domestic manufacturing and marketing application.

Education : M. Pharm


Experience : 5- 10 years experience required in Regulatory Affairs for India Market.


Employment Type: Full Time, Permanent

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What people at Sun Pharmaceutical Industries are saying

Regulatory Affairs salary at Sun Pharmaceutical Industries

reported by 2 employees with 1-6 years exp.
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₹2.5 L/yr - ₹3.2 L/yr
56% less than the average Regulatory Affairs Salary in India
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