Sr. Director, Head of Regulatory Affairs

Position: Sr. Director, Head of Regulatory Affairs

Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Therapeutics is committed to building a passionate core team of scientific, clinical, regulatory, and business leaders to bring new targeted therapies for cancer patients struggling with limited treatment options. Our focus has been and will continue to be new oncology therapeutics based on targeting the biological drivers of the cancer, regardless of tumor type.

Our team members are passionate about helping patients! If you’re looking to be a part of a lean and nimble team with significant responsibility, and contribute constructively across departments in an entrepreneurial position, we urge you to consider joining our team.

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 skillsrequired. 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 environmentis critical

• Intellectually curious with strong critical, strategic, and analytical thinking skills

• Demonstrated record of accomplishment in a dynamic environmentthrough an ability to prioritizeRain Therapeutics is an equal opportunity employer, and we’re proud of our ongoing efforts to foster diversity & inclusion in the workplace. Individuals seeking employment at Rain are considered without regard to race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.