Director, Regulatory Affairs
Global Regulatory Affairs at Kite Pharma, a Gilead Company, is responsible for developing innovative global/regional regulatory strategies and filings that will advance novel medicinal oncology products for patients.
The Director, Regulatory Affairs is a product-facing role that provides leadership in support of our development programs. This includes the development and implementation of strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with relevant requirements. This person represents the regulatory function on cross functional teams and must integrate company goals into the objectives and activities of the Global Regulatory Affairs Department.
Are you ready to preside over regulatory requirements for cell and gene therapy products? Come join us in our mission to cure cancer!
Responsibilities (include but are not limited to):
- Develop and implement regulatory product strategies
- Represent the regulatory function on cross-functional development teams
- Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies
- Plan, prepare, and review submissions including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA) throughout the lifecycle of assigned projects
- Lead and oversee 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
- Serve as the Global Regulatory Leader (GRL) for assigned Product Teams, producing global strategies and advising the US and other Regulatory Leads (e.g., USRL) in the development of strategies and execution of filings
- Supervise, analyze, and disseminate intelligence on matters that may affect development programs
- Provide interpretation of and advice regarding regulations, directives, and guidance
- Accountable for robust meeting requests, briefing documents, and coordination/ preparation of teams for meetings and interaction with regulatory authorities
- Accountable for responses to requests for information from regulatory authorities
- Train, lead, and mentor other regulatory affairs personnel
- Work externally to engage in policy initiatives
- MS/PhD/PharmD in a scientific discipline with minimum of 10 years’ experience in industry related Regulatory Affairs (or BS with 12+ years’ relevant experience)
- Experience in the preparation and submission of regulatory documents
- Demonstrated experience in 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, to include submissions of BLA/NDAs
- Knowledge and understanding of global regulations and guidelines
- 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
- Oncology drug development experience highly desired
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
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Job posted: 2020-06-02