Executive/Sr. Executive: Regulatory Affairs (Formulation) US | Sun Pharma | Vadodara

HR / Admin / Office, PharmacoVigilance / Regulatory Affairs
Gujarat
December 28, 2023
Full Time
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Job Overview

  • Date Posted
    December 28, 2023
  • Location (State / UT)
    Gujarat
  • Expiration date
    February 7, 2025
  • Experience
    2 Years, 5 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree

Job Description

Role & Responsibilities:

  • Review all data and documents related to product registrations for various health authorities.
  • Compile registration dossiers for submission to various health authorities such as the US Food and Drug Administration, Health Canada, Europe, Australia/New Zealand, Japan, and Israel. 3) Prepare responses to deficiency letters received from various agencies.
  • Maintain drug product registration dossier life-cycle/post-approval changes.
  • Offer regulatory assistance to cross-functional departments.
  • eCTD compilation, verification, and submission through an electronic gateway.

Skills:- Regulatory Affairs, USFDA, US Market

Experience: 2 to 5 Years

Location:- Vadodara, Baroda

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