Manager, Regulatory Affairs CMC with Viral Vector experience

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

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 Bachelors Degree

Specific Job Responsibilities:

• Act as the Regulatory Affairs CMC Lead for assigned clinical and commercial cell therapy programs ensuring highquality 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 crossfunctional 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 ATMPspecific expectations and practical implementation.
• Support alignment of crossfunctional 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 crossfunctional deliverables and influence stakeholders without direct authority ensuring alignment timely decisions and highquality 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.
• Selfmotivated with a strong sense of ownership and accountability.
• Comfortable operating in a fastpaced environment with changing priorities and strict timelines.
• Flexible solutionoriented mindset with the ability to adapt best practices within a growing organization.
• Proficiency with industrystandard 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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at 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 individuals 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.

Please apply via the Internal Career Opportunities portal in Workday.