Global Regulatory Lead

3 days ago


Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000

This role focuses on overseeing and managing global regulatory activities for Chemistry Manufacturing and Controls (CMC) within New Drug Applications.

Key Responsibilities:
  • Maintain the filing process, query responses, and post-approval changes globally.
  • Align the established regulatory strategy with Health Authority requirements from a global perspective.
  • Ensure timely and high-quality regulatory submissions worldwide.
Regulatory Expertise:
  • Understand global regulatory requirements, particularly for US, EU, Japan, China, and other markets.
  • Share additional data generation gap assessments with cross-functional teams.
Collaboration and Communication:
  • Closely work with consultants, partners, and local regulatory colleagues to understand regional requirements.
  • Prepare Agency consultation packages, briefing books, and presentations for consultations.
Additional Duties:
  • Provide CMC support for other branded projects as needed.
  • Coordinate with global manufacturing sites, integrate regulatory strategies, and communicate with senior management.

Responsibilities include developing a comprehensive understanding of global regulatory landscapes, collaborating with cross-functional teams, and communicating effectively with various stakeholders.



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