Global Pharmaceutical Regulatory Specialist

4 days ago


Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878

Job Title: Senior Regulatory Manager

Department: Regulatory Affairs

About This Opportunity

The Senior Regulatory Manager will be responsible for the preparation, review, and submission of high-quality regulatory dossiers and documents for pharmaceutical products intended for global markets.

  • Thorough knowledge of 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.

Key Responsibilities:

  • Regulatory Submissions & Approvals: Coordinate with agents 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.

Required Skills & Qualifications:

  • Must have experience handling international markets.
  • Strong knowledge of CTD/non-CTD formats and regulatory requirements of international markets.

What We Offer:

  • A dynamic work environment that fosters innovation and collaboration.
  • Opportunities for professional growth and development.


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