Senior Officer

4 days ago

India Maharashtra Govandi USV Full time ₹ 6,00,000 - ₹ 12,00,000 per year

Position Summary
We are seeking a Senior Officer- Regulatory affairs (Emerging Markets ) to join our team, he will be reporting to General Manager in this role, you will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approval

Job Responsibilities:

  • Collate/prepare and file dossiers in a timely and accurate manner for Formulations and API products to get licenses from various targeted markets (Emerging Markets/ROW).
  • Review and 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 vendors 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 (country specific).
  • Collate and conduct first-level review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations etc. as per the country requirements.
  • Conduct initial review of the specifications of the API / Semi-Finished Product / Finished Product as per the regulatory requirements.
  • Conduct initial review of labelling/artwork as per the market where the dossier is being filed (only formulations).
  • e-CTD compilation/ publishing of DMF / Dossiers and Submission to customer / Health Authorities.
  • Assist in resolution of queries received from customer/agency/regulator and assessing them before sharing with team leader.
  • Sharing copies of all Agency submissions pertaining to API and Approval package for FDF, with respective manufacturing sites.
  • Submission of Renewals, Re-registrations, Tender (Emerging Markets).

Proficiencies and Expertise
●M.Pharm Only
● Proven experience in Regulatory affairs with minimum 2.5 years.


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