Regulatory Affairs Specialist

4 days ago


Dholka, Gujarat, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878
Job Description:

Senior Manager Regulatory Affairs

  • Handling submissions in Sugam & NSWS Portal
  • Preparation & Submission of New Drug applications, Subsequent New Drug Applications
  • Clinical trial application - Phase I, II, III, IV (Form CT-04)
  • BA/BE Export application (Form CT-05)
  • Test License application (Form CT-10, Form CT-13, Form CT-14, Form CT-16, Form-11)
  • Manufacturing new drug & Marketing (MA) application (Form CT-21)
  • Import new drug & Marketing application (Form CT-18)
  • Form-40 & Form-10 application
  • Post approval changes
Required Skills and Qualifications:
  • Familiarity with regulatory affairs
  • Excellent communication skills
  • Ability to work in a team
Benefits:
  • Prominent role in the company
  • Opportunities for growth and development
Others:

Local candidate preferred from Ahmedabad



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