Regulatory Compliance Specialist

21 hours ago

Bikaner, Rajasthan, India beBeeCompliance Full time ₹ 25,00,000 - ₹ 60,00,000
Regulatory Compliance Specialist

The Regulatory Affairs Executive plays a pivotal role in ensuring compliance with international guidelines and country-specific requirements. This position involves preparing, reviewing, and maintaining regulatory documents to facilitate product registrations.

  1. Document Analysis: Screen and analyze documents received for product registration requests as per country-specific guidelines.
  2. Dossier Compilation: Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements.
  3. Timely Submissions: Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities.
  4. Regulatory Query Management: Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.

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.
  • Document management and record-keeping skills.

Behavioral Skills:

  • 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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