Jobid=637619402499828630 (0.051)
Description
Basic Qualifications:
Relevant industry experience is required, with focus on experience with viral vectors and/or lipid nanoparticles
Advanced degrees (or certificates) including PhD and MS are desired
8+ years in Regulatory Affairs or relevant industry experience following a Bachelor’s Degree
Specific Job Responsibilities:
Act as the Regulatory Affairs CMC Lead for assigned clinical and commercial cell therapy programs, ensuring high‑quality and timely regulatory CMC deliverables.
Contribute to the development and execution of CMC regulatory strategies, aligned with product development stage, regional requirements, and overall program objectives.
Author, review, and critically assess regulatory CMC documentation, ensuring accuracy, consistency, and compliance.
Provide regulatory CMC guidance and input to cross‑functional teams to support product development, lifecycle management, and commercialization activities.
Interpret and apply EMA, EU, Ph. Eur., and relevant RoW regulatory requirements, with a strong understanding of ATMP‑specific expectations and practical implementation.
Support alignment of cross‑functional perspectives into a consistent regulatory CMC position, balancing compliance, timelines, and operational feasibility.
Assess and evaluate proposed CMC change controls to determine their regulatory impact across clinical and commercial programs.
Ensure internal regulatory IT systems are kept accurate, up to date, and aligned with regulatory activities, enabling reliable tracking of submissions, status, and commitments across programs.
Participate in industry trade groups and regulatory professionals associations.
Take a leadership role in updating the corporation on major international CMC regulatory guidance for assigned areas of interest.
Will be expected to use industry network to maintain an awareness of the “pulse” of CMC best practices, and to disseminate this information to the corporation.
Assist in drafting background packages for meetings with Health Authorities, and may be required to develop basic strategies.
Form ad hoc task forces to address critical CMC issues on behalf of project and department teams
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.
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