Regulatory Affairs Executive – API | USV | Mumbai

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Job Overview

  • Date Posted
    October 17, 2022
  • Location (State / UT)
  • Expiration date
    August 13, 2024
  • Experience
    2 Years, 4 Years
  • Gender
  • Desired Qualification
    Master’s Degree

Job Description

  • Collect / Prepare and file dossiers in a timely & accurate manner for Formulation & API products to get licenses from various targeted markets.
  • Review & regulatory impact analysis of the change control, communication with customer for notification and approval as applicable
  • Review and regulatory impact analysis of the changes notified by the vendor as per current regulatory requirements (country-specific), as desired.
  • Evaluate any changes proposed post-approval. Prepare and file necessary amendments/ supplements/ annual reports as applicable to ensure regulatory compliance (Post-approval Life Cycle Management)
  • Prepare the checklist for documentation for regulatory fillings as per current regulatory requirements.
  • Collect & conduct a first-level review/ overview of relevant standard technical documentation like stability, TTD, PDR, and method validation.
  • Conduct initial review of labeling/ artwork as per the market where the dossier is being filed
  • e-CTD compilation/ publishing of DMF/ Dossier & Submission to customer/ Health Authorities
  • Assist in the resolution of queries received from customers/agencies/regulators and assess them before sharing them with the team leader
  • Preparation of Tech-packs for APIs
  • Prepare & e-file documents for registration of any facility used (in process for drug) with the USFDA
  • Submission of Renewals, Re-registrations, Tender

Qualification: MS/M.Sc(Science), M.Pharma