Regulatory Affairs Director
Regulatory Affairs | Santa Monica, CA | Full Time
Kite Pharma Inc, founded in 2009, is dedicated to the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to fight tumor cells. We are a dynamic and accomplished team with an exciting growth trajectory for the coming year.
The Director, Regulatory Affairs provides regulatory leadership in support of the development programs at Kite Pharma. This includes the development and implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. This person represents the regulatory function on multi-disciplinary teams and must integrate company goals into the objectives and activities of the regulatory affairs department. The successful candidate will serve as a resource to team members for the regulatory requirements to conduct drug development activities for cell and gene therapy products. This position will report directly to the VP of Regulatory Affairs.
Responsibilities (include but are not limited to):
- Develop and implement regulatory strategy
- Represent the regulatory function on cross-functional development teams
- Provide regulatory guidance and strategy including identifying and assessing regulatory risks
- Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA)
- Lead regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
- Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
- Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
- Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
- Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be primary liaison with regulatory authorities for day-to-day interactions
- Coordinate and prepare responses to requests for information from regulatory authorities
- Train and mentor other regulatory affairs personnel
- Other duties as assigned
- PhD or PharmD in a scientific discipline preferred along with at least 7 years of experience in industry‑related Regulatory Affairs (or BS/MS with at least 10 years of relevant experience)
- Knowledge and understanding of global regulations and guidelines
- Previous experience in the preparation and submission of regulatory documents
- Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
- Experience with investigational drugs, including late stage development, and marketed products
- Ability to work in a cross-functional team environment with experience managing people and project teams
- Strong attention to detail and the ability to handle multiple tasks
- Excellent organizational, computer and documentation skills and an ability to prioritize effectively
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part of the first 100 employees in this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation. Did we forget to mention the stock options? To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for one year.
No phone calls please and no agencies or recruiters