Regulatory Affairs Senior Executive

1 day ago


Mumbai, Maharashtra, India Sun Pharmaceutical Industries Full time

At Sun Pharmaceutical Industries, we are seeking an experienced Senior Regulatory Affairs Executive to join our team. This is a challenging role that requires a strong understanding of regulatory submission guidelines and ICH Quality guidances.

Job Description

The successful candidate will be responsible for ensuring compliance with all relevant regulations and guidelines. This includes:

  • Minimum 2-4 years of experience in regulatory affairs quality assurance of API Plant or corporate
  • Adequate knowledge of regulatory submission guidelines and ICH Quality guidances

In addition, the ideal candidate will have good understanding of:

  • DMF compilation and lifecycle management requirement
  • Responding agencies customer queries
  • Change control and related submission requirement

This role also requires good English speaking and writing skills, as well as appropriate knowledge of MS Word, Excel, and Power Point.



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