Process Incharge/Sr Process Incharge – Regulatory Affairs | Otsuka Pharma | Ahmedabad

HR / Admin / Office, International Business, PharmacoVigilance / Regulatory Affairs
Gujarat
July 19, 2023
Full Time
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Job Overview

  • Date Posted
    July 19, 2023
  • Location (State / UT)
    Gujarat
  • Expiration date
    February 27, 2026
  • Experience
    3 Years, 8 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

Process Incharge/Sr Process Incharge – Regulatory Affairs (ROW)

Roles and Responsibilities:

  • Dossier preparation/review as per the country-specific guideline/CTD guideline
  • Timely query response submission to Distributor/ MOH
  • Review of documents for their correctness and compliance with respective regulatory guidelines (as per country requirement)
  • Preparation, review & release of artworks & sales orders as per country approval
  • Variation documents preparation and filing as per country requirements
  • Timely dispatch of tender documents to country/parties as per the deadline

Desired Candidate Profile:

  • Should be able to review & interpret the requirement as per country-specific/ tender guideline
  • Should be able to review various plant documents for dossier preparation like Process validation, Stability study, PDR, Method validation, SOP, Drug Master file, BMR, APR, etc.
  • Should be able to handle a team of two members
  • Should be able to communicate with relevant functions for procurement of required regulatory documents
  • Should be able to communicate with relevant counterpart at country
  • Preferred Immediate joiners

Qualification: B Pharma, M. Pharma

Experience: 3 – 8 years

Perks and benefits: 5 Days working & other benefits

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