Head - Regulatory Affairs

India Pharma People
  • Mumbai
  • Confidential
  • 9-14 years
  • 12 Aug 2015

  • Compliance/ Regulatory

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Job Description:

To prepare dossiers for registration of Products for Indian Market
- To have good personal contacts in DCGI.
- To deal with regulatory bodies.
- To be involved in the dealings with the registration authorities at the top level and to get the products registered.
- To provide inputs to the preparation and submission of dossiers, Marketing Authorization Applications for new drugs.
- To assure conformity of dossiers to the local statutory requirements.
- To submit dossiers for local products, like renewals of MAA or Variations, such as labeling changes, line extensions, pharmaceutical changes (drug product composition, manufacturing site, etc).
- To prepare the dossiers for price/reimbursement of the products with the Marketing and Medical Affairs interfaces.
- To validate the pharmaceutical dossiers on the existing products.
- To update the registration databases (sometimes different in the Affiliates and Corporate) and local regulations.
- To have active and effective contacts with Corporate Regulatory Affairs and with colleagues in other Affiliates, occasionally.
- To maintain permanent relationship and frequent contacts with the Health Authorities.

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India Pharma People