Project / RA Submission Management Associate II

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

Job Description

Kite is seeking a highly motivated individual to join us as an Associate II, Project Management, to work in the exciting area of cancer immunotherapy. This position will provide project management and regulatory filing support to the global Regulatory CMC team in a dynamic and fast paced organization and contribute to the timely execution of CMC strategy in a cell therapy setting. The preferred candidate will possess strong interpersonal skills as this position interacts with all levels of employees in Technical Operations (Process Development, Quality, Supply Chain, Manufacturing), and Regulatory Affairs across multiple geographies.

Responsibilities:

• Drive cross-functional submission project teams and manage regulatory submission deliverables; may partner with a more senior project manager on larger projects.
• Develop and maintain submission timelines (e.g. Gantt charts), risk management strategies and risk/issue logs, meeting minutes, decision and action item logs, and other project management tools.
• Partner with Regulatory CMC and Technical Operations to ensure the coordinated preparation and completion of regulatory documents for submissions and requests for information.
• Manage regulatory submission documents including file organization, transfer between systems, and traceability from draft through approval and publishing.
• Foster productive communication and alignment across Regulatory Affairs functions—including Regulatory CMC, Regional Regulatory Leads, Labelling, Regulatory Operations, and other relevant stakeholders—while ensuring effective coordination between Regulatory CMC and Technical Operations through proactive facilitation, networking, and timely updates on progress and issues (e.g., project dashboards and reporting).
• Support the optimization and deployment of business processes and tools to improve efficiency and advance collaboration.

Requirements:

• BA/BS degree with 4+ years of experience in Life Sciences, Biotechnology, Pharmacy, or related technical field.
• MA/MS or MBA with 2+ years of aforementioned experience.

Additional qualifications and information:

• Experience managing multiple projects simultaneously with strong organizational skills and attention to detail.
• Knowledge of the drug development process, cell therapy industry, and Regulatory CMC practices; Module 3 experience strongly preferred.
• Demonstrate the ability to take the initiative to think critically and troubleshoot problems.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Ability to interact with staff at all levels in a fast-paced environment, remaining flexible, resourceful, and efficient, with a high level of professionalism and confidentiality.
• Proficient in MS Word, Excel, Power Point, Outlook, Teams, SharePoint; Smartsheet and other project/productivity tools experience a plus.
• Experience in Veeva Vault platform and AI tools.

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.