Senior Director, Head of Regulatory Affairs

BACK

Rain Therapeutics is committed to building a passionate team of core business leaders to execute on our vision to identify, and execute on the development, of novel treatments for patients with cancer.  Rain 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.  Rain is 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.

Summary:

The role 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.  Key to this role will be furthering the development of tarloxotinib (Tarlox) for non-small cell lung cancer (NSCLC) harboring EGFR / HER Exon 20 insertion mutations.  The right candidate will be highly skilled at communicating with, and influencing, cross-functional colleagues in order to guide the team toward regulatory milestones.  The Senior Director, Regulatory Affairs will report directly to the CEO of Rain Therapeutics.

Critical Job Responsibilities:

  • Represent Regulatory Affairs when interacting with various company departments to manage activities and coordinate the preparation of regulatory submissions
  • 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
  • Lead and facilitate meetings or other interactions with health authorities
  • Oversee regulatory vendors supporting operational activities
  • Lead the development of SOPs affecting core Regulatory deliverables (DSUR, 1572 submissions, etc.)
  • Identify regulatory risks and threats while developing mitigation strategies
  • Remain current with FDA and international regulatory guidance relevant to oncology and orphan drug development

Preferred Education and Experience:

  • 8+ years in Regulatory Affairs, including 2+ years as the US/Global Regulatory Leader for clinical-stage development programs
  • Oncology drug development experience highly desirable
  • Experience leading FDA meetings and teleconferences required
  • Hands-on experience working in small companies and small teams desirable
  • Highly proficient oral and written communication and excellent interpersonal skills required. A proven influencer
  • Desire and experience to build a regulatory function from the ground up, tapping vendors where appropriate
  • Demonstrated ability to collaborate successfully with multiple functions in a team environment is critical
  • Intellectually curious with strong critical, strategic, and analytical thinking skills
  • Demonstrated record of accomplishment in a dynamic environment through an ability to prioritize