Senior Regulatory Compliance Officer

2 days ago

Bhavnagar, Gujarat, India beBeeCompliance Full time ₹ 12,90,000 - ₹ 20,16,000
Regulatory Compliance Specialist

This is a pivotal role ensuring compliance with international guidelines and country-specific requirements.

The position involves coordinating with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and adherence to regulatory standards.

Main Responsibilities
  • Screen and analyze documents for product registration requests according to 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 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 and tracking timelines.
  • 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.
Key Qualifications
  • Familiarity with 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.
About This Opportunity
  • This is an individual contributor role reporting to the Assistant Manager - RA.

By joining our organization, you will have the opportunity to work effectively under pressure and meet strict deadlines, as well as develop strong collaboration and coordination skills.

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