Principal Consultant

3 days ago


Australia beBeeRegulatory Full time $180,000 - $220,000

Regulatory Leadership Opportunity

About the Role
  • Pursue strategic regulatory approaches for complex products.
  • Mentor and grow a high-performing team of professionals.

This seasoned CMC and Regulatory Affairs Principal Consultant will shape the regulatory strategy of clients' intricate products. Collaborating closely with cross-functional teams, you'll author and review impactful regulatory documents and represent clients in meetings with regulatory agencies.

Key Responsibilities
  • Develop innovative product strategies for biologics, vaccines, and cutting-edge therapies.
  • Navigate FDA, EMA, and ICH guidelines to ensure compliance.
  • Create and review crucial regulatory documentation.
  • Represent clients effectively in agency meetings.
  • Lead successful international programs.

Requirements

  • At least 10 years of experience in regulatory submissions and interactions with agencies.
  • Demonstrated expertise in CMC development and regulatory affairs.
  • A strong background in consultancy, strategic planning, and leadership.


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