Regulatory Affairs Expert

18 hours ago

Vadodara, Gujarat, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 15,00,000
Regulatory Affairs Specialist

This is a key role in ensuring regulatory compliance across various product categories. The successful candidate will be responsible for preparing, reviewing and maintaining regulatory documents to meet international guidelines and country-specific requirements.

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

The ideal candidate will possess a strong understanding of global regulatory guidelines, excellent organizational and analytical skills, and proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.

  • 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 (e.g., DOC, COA) 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.

Key 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.
  • Document management and record-keeping skills.

Behavioral Traits:

  • 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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