Regulatory Affairs Specialist

5 days ago

Ghaziabad, Uttar Pradesh, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000

Job Opportunity: Regulatory Affairs Professional

The Regulatory Affairs Executive plays a crucial role in ensuring compliance with international guidelines and country-specific requirements. This involves preparing, reviewing, and maintaining regulatory documents 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.
  • Compile, review and manage product dossiers in compliance with customer and regulatory requirements.
  • Prioritize dossier compilation and submission to meet defined timelines and ensure timely submission to regulatory authorities.
  • Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
  • Arrange supportive batch-related documents for registration samples.
  • Manage the legalization or apostillation of registration documents, including coordination with agencies and tracking timelines.
  • Support the Compliance team by providing updated documents required for technical file preparation.
  • Review and update Technical Master Files periodically to ensure consistency across product categories.
  • Coordinate with cross-functional teams to fulfill regulatory requirements and address audit queries.
  • Prepare and submit documents related to audit findings in a timely manner.
Required Skills:
  • 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.
Behavioral Requirements:
  • 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.

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