Regulatory Affairs Specialist

1 week ago

Pushkar, Rajasthan, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 15,00,000

Regulatory Affairs Professional

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The primary goal of this position is to ensure that all regulatory documents are accurately prepared, reviewed, and maintained in compliance with international guidelines and country-specific regulations. This involves coordinating with internal teams and external stakeholders to facilitate product registrations, timely dossier submissions, query responses, and adherence to regulatory standards.

Key Responsibilities:

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  • Screen and analyze documents received for product registration requests according to country-specific requirements.
  • Prepare, compile, and review product dossiers in accordance with customer and regulatory demands.
  • Prioritize dossiers to meet defined timelines and guarantee timely submission to the regulatory authorities.
  • Draft and coordinate responses to regulatory queries with supporting documentation and justifications.
  • Arrange necessary batch-related documents (e.g., certificates of analysis) for registration samples.
  • Manage legalization or apostillation of registration documents, including coordination with relevant 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 (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries.
  • Ensure timely preparation and submission of documents related to audit findings.
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