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Vice President, Regulatory Strategy

Vice President, Regulatory Strategy

Advanced ClinicalRedwood City, CA, United States
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Join to apply for the Vice President, Regulatory Strategy role at Advanced Clinical

The Opportunity

The Vice President, Regulatory Strategy will lead and expand a high-performing team responsible for delivering clinically focused global regulatory strategies across a dynamic oncology pipeline. This role will shape the vision, build organizational capabilities, and ensure regulatory excellence from early development through global commercialization.

Must be willing to work onsite 3 days / week based in San Francisco, CA

Key Responsibilities

  • Provide ethical, mission-driven leadership for the Regulatory Strategy function.
  • Define and execute a clear vision for the organization, scaling capabilities to meet the demands of a robust pipeline in high unmet medical need areas.
  • Oversee the development and delivery of high-quality, globally relevant regulatory research, strategies, and guidance to project teams, working groups, and executive leadership.
  • Partner closely with cross-functional leaders to ensure sound, collaborative decision-making.
  • Integrate regulatory considerations early in development, including target product profiles, clinical development plans, and financial planning.
  • Promote consistency in regulatory approaches and foster continuous learning across the organization.

Required Qualifications

  • Based in the San Francisco Bay Area and able to work onsite.
  • BA / BS in life sciences or related field; advanced degree preferred.
  • Minimum 16 years of experience in regulatory affairs within drug development.
  • At least 6 years in a senior regulatory leadership or executive role.
  • Extensive Phase III oncology drug development experience.
  • Proven expertise in navigating global regulatory environments and submitting global marketing applications.
  • Demonstrated success managing and developing a team of 5+ professionals.
  • Deep understanding of the strategic role regulatory plays in oncology drug development and commercialization.
  • Seniority level

  • Executive
  • Employment type

  • Full-time
  • Job function

  • Business Development and Sales
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