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Sr. director, head of regulatory affairs

Meet

This is a Full-time position in San Francisco, CA posted December 20, 2019.

Summary Meet is partnered with a growing, privately funded oncology biotech seeking a Sr.

Director, Head of Regulatory Affairs to be based in the East Bay.

You will be responsible for developing and leading regulatory strategies to ensure the successful development and commercialization of novel therapeutic oncology products.

The position will also be responsible for building a high performing regulatory team and for identifying appropriate vendors to support business critical activities.

Reports into the CEO.

Comppany Overview Our client is committed to the development of novel cancer treatments by bringing together people who are passionate, creative, and experienced at building a vision and executing on strategy.

They are shaped by self-motivated entrepreneurs who like to build teams to achieve goals for the benefit of patients suffering from diseases with unsatisfactory treatment options.

Role Responsibilites Provide strategic regulatory advice, interpret guidance, and apply precedent where applicable Build the Regulatory function and advise corporate management on regulatory opportunities during product development Serve as the company contact with major health authorities, including FDA Skills Required 8+ years in Regulatory Affairs, including 2+ years as the US/Global Regulatory Leader for clinical-stage development program Oncology drug development experience and hands-on experience working in small companies and small teams highly desirable Experience leading FDA meetings and teleconferences required