Regulatory Affairs Specialist

7 days ago


Vizag, Andhra Pradesh, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,01,00,000
Regulatory Affairs Role

The main objective of this position is to ensure compliance with international guidelines and country-specific requirements.

This role involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.

Key Responsibilities
  • Screen and analyze documents for product registration requests as per country-specific guidelines.
  • Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements.
  • Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities.
  • Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
  • Arrange supportive batch-related documents for registration samples.
  • Manage legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments/invoices.
  • Support the Compliance team by providing updated documents required for technical file preparation.
  • Periodically review and update Technical Master Files to ensure consistency across product categories.
  • Coordinate with cross-functional teams to fulfill regulatory requirements and address audit queries.
  • Ensure timely preparation and submission of documents related to audit findings.


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