Sr Manager, Regulatory Affairs CMC

We need to output HTML fragment with sections: About the role? The posting includes a description paragraph before "Job Description". We need to use

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include sections only when posting has real specific content. We have content for Responsibilities (list), Knowledge And Technical Skills (maybe Skills), Core Capabilities (maybe Skills), Leadership and Impact (maybe Skills), Personal Attributes (maybe Skills), Basic Qualifications (Requirements), Preferred Qualifications (maybe Requirements or Skills), People Leader Accountabilities (maybe Skills?), Salary range (Pay), Benefits (Benefits), Schedule (flexible working policy: two days remote, three days onsite). Also location relocation info maybe part of About the role? Could be included in About the role paragraph. We must not repeat job title as heading. No Job ID. Remove boilerplate like EEO, legal, etc. Also remove navigation, cookie, etc. Also remove application instructions (none). Also remove duplicated lines. We need to preserve all substantive info. So we need to extract paragraphs and lists. Let's structure:

About the role

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. 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.

The Senior Manager, Regulatory Affairs CMC supports and drives increasingly complex CMC regulatory activities for Kite’s cell therapy / CAR-T portfolio across clinical and commercial development. This role contributes to the development and execution of global regulatory strategies, supports end-to-end preparation of CMC submissions, and partners closely with cross-functional teams to help ensure timely, high-quality, and compliant regulatory deliverables throughout the product lifecycle. This includes support for key areas such as vector-related changes, manufacturing network expansion, lifecycle management, and inspection readiness. The role is expected to operate with considerable independence within assigned scope and contribute meaningfully to both program execution and functional best practices. Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA or El Segundo, CA office beginning in January 2027. While this role will be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite.

That covers About the role and also includes schedule info (flexible working). But schedule section separate maybe. However schedule content is in that paragraph. Could still include schedule section separate but we would duplicate. Better to keep schedule info in About the role? The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should have separate sections for each if content exists. So we need a Schedule section with the flexible working policy. The About the role should not include schedule details? It can still include but we might duplicate. Better to keep About the role generic mission and role overview, and move schedule details to Schedule section. However we must preserve all substantive info; we can still mention schedule in Schedule section and not repeat in About the role. Let's extract schedule: "Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite." That's schedule. Thus About the role paragraph will exclude that sentence. We'll keep other info. Now Responsibilities: list of bullet points after "Responsibilities include, but are not limited to:" then many items each starting with a verb. We'll put each as

. We need to ensure we capture all responsibilities items. Let's list them: - Support and drive operational and lifecycle management activities for Regulatory CMC submissions across Kite’s global cell therapy / CAR-T clinical and commercial programs. - Prepare, coordinate, and critically review moderately complex to complex CMC regulatory submissions in accordance with ICH requirements, applicable regional requirements, and internal scientific and procedural standards. - Contribute to the preparation and submission of CMC content for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, and post-approval submissions supporting cell therapy products. - Support development and execution of global CMC regulatory strategies aligned with program objectives, business timelines, and evolving health authority expectations for ATMP / CAR-T products. - Help ensure global harmonization and consistency of Module 3 content across applications, regions, and lifecycle activities. - Identify CMC risk areas and recommend practical mitigation strategies, alternative approaches, and scenario planning to support complex cell therapy manufacturing and supply strategies. - Serve as a Regulatory CMC representative on cross-functional project teams, partnering closely with Technical Operations, MSAT, Process & Analytical Development, Quality, Manufacturing, Supply Chain, and Clinical stakeholders. - Support regulatory strategy and execution associated with vector-related changes and comparability considerations, as applicable to CAR-T product development and lifecycle management. - Provide regulatory input for manufacturing site expansion activities, including addition or qualification of new manufacturing sites, updates to registered details, and related post-approval or clinical submission strategies. - Contribute to inspection readiness activities, including support for regulatory responses and documentation related to site readiness, manufacturing history, inspection history, and pre-approval or routine inspection planning. - Support preparation of health authority responses (e.g., IRs, RTQs, deficiency responses) and contribute to briefing materials and meeting support for CMC-related agency interactions. - Assess manufacturing change controls for potential global regulatory impact and provide input on compliant and efficient implementation strategies across regions. - Support maintenance and accuracy of CMC-specific registered details and associated documentation in relevant systems and repositories. - Present project status updates, key risks, and regulatory considerations for assigned programs in group meetings and cross-functional forums. - Contribute to continuous improvement initiatives, including templates, tools, policies, procedures, and knowledge-sharing activities that strengthen Regulatory CMC capabilities and submission quality. - May lead or contribute to CMC RA sub-teams or special initiatives within the function and provide matrix support or coaching to less experienced colleagues, as appropriate. Now Knowledge And Technical Skills: list of bullet-like sentences. We'll treat as Skills section. Items: - Strong understanding of CMC regulatory requirements for ATMPs / cell therapy products, including global regulatory frameworks and regional expectations. - Knowledge of ICH requirements and current global trends in CMC Regulatory Affairs relevant to clinical and commercial products. - Experience authoring or coordinating CMC sections of regulatory submissions and supporting lifecycle management activities. - Ability to interpret regulatory guidance and apply it to practical product, process, and manufacturing scenarios. - Understanding of regulatory considerations for CAR-T manufacturing, comparability, product lifecycle changes, and site-related updates is preferred. - Ability to assess risk, support strategy development, and partner effectively across technical functions in a fast-paced environment. Now Core Capabilities: list. - Strong cross-functional collaboration and stakeholder partnership skills. - Ability to work with considerable independence while maintaining alignment with leadership and team priorities. - Effective written, verbal, and interpersonal communication skills in a highly collaborative environment. - Strong organizational skills, attention to detail, and ability to manage multiple priorities with shifting timelines. - Sound judgment and ability to propose practical, compliant, and risk-based solutions. - Ability to contribute to strategic discussions while remaining execution-focused and detail-oriented. - Proven ability to operate effectively in a dynamic, evolving environment with a strong sense of ownership and accountability. Leadership and Impact: - Operates with considerable independence within assigned scope and supports increasingly complex regulatory workstreams and projects. - May act as a core team member on broader cross-functional teams and may lead selected CMC RA sub-team activities for assigned programs. - Contributes to advancement of Regulatory CMC best practices through process improvements, capability-building, and knowledge sharing. - May coach or guide less experienced colleagues and contribute to a collaborative, high-performing team environment. - Models professionalism, integrity, accountability, and strong partnership behaviors in all interactions. Personal Attributes: - Highly organized, detail-oriented, and adaptable in a dynamic business environment. - Self-motivated with a strong sense of ownership and accountability. - Strategic, proactive, and solution-oriented mindset. - Comfortable navigating complex issues, evolving priorities, and fast-paced timelines. - Collaborative team player with strong professionalism, ethics, and integrity. Basic Qualifications: - Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR PhD with 0+ Years' Experience Preferred Qualifications: - Degree in life sciences, biotechnology, pharmaceutical sciences, chemistry, engineering, or a related scientific field. - Significant experience in Regulatory Affairs CMC within the biotechnology or biopharmaceutical industry. - Experience supporting cell therapy / ATMP / CAR-T programs across clinical and/or commercial stages. - Experience supporting global regulatory filings and lifecycle management for complex products, including post-approval submissions and health authority interactions. - Familiarity with vector-related regulatory considerations, comparability strategies, and complex manufacturing changes is highly desirable. - Experience with multi-site manufacturing strategies, site expansion activities, or global change management is preferred. - Experience supporting or participating in inspection readiness activities and regulatory responses related to manufacturing sites is a plus. - GMP knowledge or experience is strongly preferred. People Leader Accountabilities: maybe part of Skills or separate? Could be a section but not in list of headings. Could put under Skills or maybe under Responsibilities? But we have headings list: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. People Leader Accountabilities could be considered Skills or maybe Requirements? It's about leadership competencies. Could fit under Skills. We'll include under Skills as additional items. But we already have Skills section with Knowledge And Technical Skills, Core Capabilities, Leadership and Impact, Personal Attributes, People Leader Accountabilities. Could combine all into one Skills section with subheadings? But we only allowed

for section headings, not subheadings. Could just list all bullet items under Skills. That would be a long list but okay. Alternatively we could split into multiple sections: Skills, Requirements, Qualifications. But we have both Requirements and Qualifications headings. Basic Qualifications could go under Requirements. Preferred Qualifications under Qualifications. That seems appropriate. Thus: - Requirements: Basic Qualifications. - Qualifications: Preferred Qualifications. - Skills: Knowledge And Technical Skills, Core Capabilities, Leadership and Impact, Personal Attributes, People Leader Accountabilities. Now Benefits: list of benefits: company-sponsored medical, dental, vision, and life insurance plans*. Also mention discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Also mention eligibility for benefit plans. We'll capture. Pay: Salary range: $143,225.00 - $185,350.00. Also note that actual compensation may vary, discretionary bonus etc. But we already captured bonus in Benefits maybe. We'll keep Pay section with salary range and note that actual compensation will vary based on experience, qualifications, location. Could also mention discretionary annual bonus and stock-based incentives but those are benefits. We'll keep Pay as salary range. Schedule: flexible working policy: two days remote, three days onsite. Now About the role: we need to craft paragraph(s) covering mission and role description excluding schedule and maybe relocation? Relocation info is part of role location; we can keep in About the role. Let's draft About the role:

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