Manager, Regulatory Affairs CMC with Viral Vector experience

Required Skills and Experience

• Sound understanding of regulatory requirements, including ICH and regional requirements for assigned territories, and understanding of current global and regional trends in Regulatory Affairs CMC.
• Proven ability to drive cross‑functional deliverables and influence stakeholders without direct authority, ensuring alignment, timely decisions, and high‑quality execution.
• Skilled in building trust and rapport quickly, establishing effective working relationships across functions, sites, and geographies.
• Ability to align diverse perspectives into a single, coherent regulatory CMC strategy, balancing compliance, timelines, and operational feasibility.
• Strong affinity for language and written communication, with demonstrated experience in reviewing, drafting, and editing regulatory, scientific or technical documents.
• Excellent command of English, both written and verbal, with the ability to convey complex scientific and regulatory concepts clearly and precisely. Proficiency in Dutch a plus.
• Strong organizational skills with attention to detail.
• Self‑motivated with a strong sense of ownership and accountability.
• Comfortable operating in a fast‑paced environment with changing priorities and strict timelines.
• Flexible, solution‑oriented mindset with the ability to adapt best practices within a growing organization.
• Proficiency with industry‑standard software 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. 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.
 

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.