Chief Regulatory Documentation Coordinator

1 day ago

Hubli, Karnataka, India beBeeCompliance Full time ₹ 9,00,000 - ₹ 15,00,000
Regulatory Affairs Specialist Role Summary

This Regulatory Affairs Specialist role involves preparing, reviewing, and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements. Key responsibilities include coordinating with internal teams and external stakeholders to support product registrations, dossier submissions, query responses, and compliance with regulatory standards.

The ideal candidate will have a strong understanding of global regulatory guidelines and dossier preparation, with excellent organizational and analytical skills. Proficiency in MS Office and document management systems is also required.

  • Key Responsibilities:
  • Screen and analyze documents received 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 (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.
  • Adhere to departmental priorities and provide support for additional tasks as assigned.
  • Functional Skills Required:
  • Knowledge of international regulatory requirements and guidelines.
  • Expertise in dossier compilation, review, and submission processes.
  • Ability to prepare and analyze technical and compliance-related documentation.
  • Familiarity with audit documentation and regulatory query management.
  • Document management and record-keeping skills.
  • Behavioral Skills Required:
  • Strong attention to detail and accuracy.
  • Ability to work effectively under pressure and meet strict deadlines.
  • Team player with strong collaboration and coordination skills.
  • Proactive, adaptable, and willing to take initiative.
  • Professional communication and interpersonal skills.

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