Regulatory Affairs Director

2 days ago


California, United States Meet Full time
Regulatory Affairs and Quality Assurance Leader

We are seeking a seasoned Regulatory Affairs and Quality Assurance professional to join our client's team as a Vice President/Senior Vice President. This hybrid role will be based in the San Francisco Bay Area and will report directly to the C-Suite.

Key Responsibilities:

  • Lead the Regulatory Affairs and Quality Assurance functions, ensuring compliance with regulatory requirements and industry standards.
  • Manage all aspects of Regulatory submissions, including IND/CTA, NDA/BLA/MAA, and other regulatory documents.
  • Develop and maintain relationships with FDA and other ex-US Health Authorities, ensuring effective communication and compliance.

Requirements:

  • 20+ years of industry experience, with a minimum of 10 years of management/leadership experience.
  • Oncology experience is required, with a strong understanding of the Heme/Onc space.
  • Full development cycle experience is required, from pre-IND through commercial.
  • Startup experience is highly preferred.

About Meet:

Meet is a leading search firm specializing in the life sciences industry. We are committed to delivering exceptional results and building long-term relationships with our clients and candidates.



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