Associate Director, Regulatory Affairs

Cambridge, MA

JOB TITLE: Associate Director, Regulatory Affairs
EFFECTIVE DATE: August 15, 2019
CLASSIFICATION: Full time Employee
FUNCTIONAL AREA: Regulatory
WORK LOCATION: Cambridge, MA
SUPERVISOR: Vice President, Regulatory
MANAGERIALLY RESPONSIBLE FOR: N/A

ESSENTIAL JOB FUNCTIONS:

  1. Contribute to the development and implementation of regulatory strategies for specific projects.
  2. Active involvement in the coordination, writing and review of applications for clinical trials, new marketing applications and other regulatory submissions (e.g. Orphan drug designation, Breakthrough designation, IND/NDA amendments and supplements, Pediatric study plans, labeling documents)
  3. Assist in developing response strategies to Agency queries
  4. Ensure the quality and regulatory compliance of all documents to be submitted to regulatory agencies
  5. Provide regulatory support to nonclinical, clinical and CMC project teams
  6. Assist in the management of regulatory agency interactions, document preparation, coordination of rehearsals and minutes
  7. Contribute to building regulatory intelligence capabilities

JOB SPECIFICATIONS:

  1. Minimum 8+ years pharmaceutical/biotechnology industry experience, 5 plus years of regulatory experience
  2. Bachelors degree in life science
  3. Excellent written and spoken communication skills
  4. Attention to detail
  5. Strong organizational skills
  6. Strong interpersonal skills
  7. Solid working knowledge of drug development process
  8. Knowledge and understanding of US and ex-US regulations
  9. Experience and knowledge in the preparation of electronic submissions
  10. CMC experience a distinct advantage
  11. Oncology experience highly desirable

WORK ENVIRONMENT:

Employee frequently works in a professional office environment and lab with lots of computer/lab equipment, tools, and moderate amounts of noise and activity.  Employee may occasionally be required to travel.  The work environment is fast-paced and demanding. Off-shift, weekend and overtime duties may be required as assigned by the manager.

Kura Oncology offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to careers@kuraoncology.com