Director, Regulatory Affairs
About The Position
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. At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. 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 behaviors, decisions, and actions. The 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. To succeed, the candidate will have a sustained reputation for a values-driven, collaborative, engagement style where integrity and the consideration of our Patients drives decisions and actions.
Requirements
- 10+ years pharmaceutical/biotechnology industry experience, 5 plus years of regulatory experience
- PharmD/MS preferred, or Bachelors degree in life science
- Excellent written and spoken communication skills
- Attention to detail
- 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
- 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
Nice To Haves
- Experience supporting NDAs and working on post-approval products, drug labeling experience would be great
- Hematology/Oncology or orphan-drug experience are preferred
Responsibilities
- 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.
- Provides 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.
Benefits
- Career advancement/ development opportunities
- 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!
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
