Global Pharmaceutical Regulatory Expert

2 days ago

Surat, Gujarat, India beBeeCompliance Full time ₹ 9,87,654 - ₹ 12,34,567
Regulatory Affairs Specialist

The ideal candidate will be responsible for preparing, reviewing, and submitting high-quality regulatory documents for pharmaceutical products intended for international markets.

  • Dossier Preparation & Review: Prepare and review CTD/eCTD/non-CTD dossiers for new product registrations, renewals, and variations for international markets.
  • Ensure dossiers are in line with current regulatory guidelines and client expectations.
  • Regulatory Submissions & Approvals: Coordinate with external partners for regulatory submission and queries.
  • Track and manage timelines for submissions and approvals to ensure compliance with project milestones.
  • Regulatory Intelligence & Compliance: Monitor changes in regulatory guidelines and keep relevant stakeholders informed.
  • Lifecycle Management: Manage regulatory documentation for product variations, renewals, packaging/labelling updates, and post-approval changes.
  • Audit & Documentation: Maintain and update regulatory databases and trackers.

Required Qualifications & Experience:

  • Must have experience handling international markets.
  • Strong knowledge of CTD/non-CTD formats and regulatory requirements of international markets.
  • Experience in dealing with distributors/agents for regulatory submissions.

Key Skills:

  • In-depth understanding of pharmaceutical regulatory processes.
  • Strong documentation and technical writing skills.
  • Ability to interpret and apply regulatory guidelines effectively.
  • Excellent communication, coordination, and project management skills.
  • Proficiency in MS Office and regulatory databases.
About This Role

This is a fantastic opportunity to join our team as a Regulatory Affairs Specialist. As a key member of our team, you will be responsible for ensuring that our pharmaceutical products meet the highest standards of quality and regulatory compliance.

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