Job Description
ESSENTIAL JOB FUNCTIONS
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.
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.
JOB SPECIFICATIONS
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
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
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 Director level is $226,495 - $258,817 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.
Kura’s Values that are used for candidate selection and performance assessments
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
The Kura Package
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!
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.
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Job Tags
Summer holiday, Work at office, Home office