Global Regulatory Affairs Professional

3 hours ago

Udaipur, Rajasthan, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,20,00,000
Compliance Specialist

This role is crucial in ensuring regulatory compliance with international guidelines and country-specific requirements.

The Compliance Specialist plays a vital part in the organization by preparing, reviewing, and maintaining regulatory documents, coordinating with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.

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.
Requirements:
  • Bachelor's/Master's degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
  • Strong attention to detail and accuracy.
  • Ability to work effectively under pressure and meet strict deadlines.
  • Team player with strong collaboration and coordination skills.
Functional Skills Required:
  • Knowledge of international regulatory requirements and guidelines.
  • Expertise in dossier compilation, review, and submission processes.
  • Familiarity with audit documentation and regulatory query management.

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