Assoc Dir/Director, Regulatory Affairs

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviours, decisions, and actions.

The Assoc Dir/Director, Regulatory Affairs will be responsible for developing, implementing, and providing guidance on US and global regulatory strategies to support development of Kura's oncology and hematology portfolio. The individual must possess excellent judgment, organizational and planning skills along with exceptional written and verbal communications.

• Contribute to the development and implementation of regulatory strategies for assigned projects.
• Lead and oversee the preparation, submission, approval, and maintenance of regulatory applications (e.g., IND/CTA, NDA/MAA, designation requests, pediatric study plans, etc.).
• Lead and/or assist in authoring regulatory documents and developing responses to Agency queries; manage submissions in coordination with regulatory operations.
• Lead and/or assist in the management of regulatory agency communications and interactions, preparation of briefing materials, coordination of rehearsals and minutes.
• Advise cross-functional development teams on regulatory requirements for development and approval pathways, including potential expedited pathways.
• Advise cross-functional teams and line management on regulatory risks, considerations, and strategies for program(s).
• Ensure activities and regulatory submissions are compliant with relevant laws, regulations, and guidances.
• Provide strategic and technical regulatory input for key product development documents.
• Perform regulatory research and intelligence to continually inform project teams of the evolving regulatory landscape and to identify changes and potential strategic implications.

• Minimum 8+ for Associate Director, and 10+ years pharmaceutical/biotechnology industry experience, 5 plus years of regulatory experience.
• PharmD/MS preferred, or Bachelors degree in life science.
• Experience supporting NDAs and working on post-approval products, drug labeling experience would be great.
• Experience leading IND/CTA submissions for clinical trials.
• Excellent written and spoken communication skills.
• Strong organizational skills.
• Strong interpersonal skills.
• Solid working knowledge of drug development process.
• Experience with planning and managing IND/CTA submissions.
• Experience working and interacting directly with FDA and/or other agencies.
• Good understanding of US and EU regulatory landscape.
• Hematology/Oncology or orphan-drug experience are preferred.
• Demonstrated ability to think critically and analyze scientific information while paying close attention to detail.
• The ability to influence and negotiate professionally at various levels within the project team and with external partners.

The base range for this role at the Associate Director level is $172,521 - $202,540 and Director level is $216,799 - $249,862 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

• We work as one for patients.
• We are goal-focused and deliver with excellence.
• We are science-driven courageous innovators.
• We strive to bring out the best in each other and ourselves.

• Competitive comp package.
• Bonus.
• 401K + Employer contributions.
• Generous stock options.
• ESPP Plan.
• 20 days of PTO to start.
• 18 Holidays (Including Summer & Winter Break).
• Generous Benefits Package with a variety of plans available with a substantial employer match.
• Paid Paternity/Maternity Leave.
• In-Office Catered lunches.
• Home Office Setup.
• Lifestyle Spending Stipend.
• Commuter Stipend (Boston Office).
• Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.