Manager, Regulatory Affairs CMC

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.

Job Description

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

The Manager Global Regulatory CMC will support Kites autologous CAR T cell therapy portfolio providing regulatory CMC leadership for global clinical development and commercial expansion across multiple regions. This role is responsible for CMC regulatory submissions lifecycle management and change management in alignment with global regulatory strategy and business objectives. The individual will serve as a key Regulatory CMC representative on cross functional program teams partnering closely with Technical Operations Quality Process Development Analytical Manufacturing and Global Regulatory Affairs.

Located in Santa Monica CA (onsite/hybrid).

Key Responsibilities

• Lead all operational and lifecycle management aspects of Regulatory CMC submissions (e.g. INDs IMPDs BLAs MAAs variations amendments) supporting global clinical and commercial CART programs

• Serve as the Regulatory CMC lead on assigned program and/or platform teams applying advanced knowledge of global CMC regulatory requirements for autologous cell therapies

• Author review and coordinate Module 3 (M3) content ensuring global alignment and harmonization across regions (US EU and other international health authorities)

• Develop and execute CMC regulatory strategies that align with overarching regulatory and business strategies including support for global site additions process changes raw material changes analytical updates and shelflife extensions

• Proactively identify CMC regulatory risks and lead scenario planning including anticipation of regulator questions and development of mitigation and contingency plans

• Assess and provide regulatory impact evaluations for CMC changes through formal change control processes ensuring appropriate global regulatory strategies are defined and executed

• Support interactions with global health authorities by contributing to briefing packages written responses and regulatory meeting preparations specific to CMC topics

• Collaborate crossfunctionally to ensure CMC deliverables meet regulatory requirements quality standards and program timelines

• Support continuous improvement and bestpractice sharing for Regulatory CMC processes in a rapidly growing dynamic environment

Basic Qualifications

• Bachelors degree in a scientific discipline (e.g. Chemistry Biochemistry Biology Chemical Engineering or related field) with 6 years of relevant Regulatory CMC and/or drug development experience including direct experience with FDAregulated products or a masters degree in related scientific discipline and 4 years of relevant experience as listed above.

• Experience supporting biologics and/or cell or gene therapy products is strongly preferred

Preferred Qualifications

• Experience with autologous CART cell therapy or advanced therapy medicinal products (ATMPs)

• Working knowledge of global regulatory requirements (FDA EMA and other international agencies)

• Experience supporting both clinical development and commercial lifecycle management

Skills and Competencies

• Strong written and verbal communication skills with the ability to translate complex CMC topics for diverse stakeholders

• Highly organized detailoriented and comfortable managing multiple priorities in a fastpaced environment

• Demonstrated ability to operate effectively in crossfunctional matrixed teams

• Selfmotivated with a strong sense of ownership accountability and followthrough

• Ability to adapt quickly to evolving regulatory landscapes and business needs

• High degree of professionalism integrity and ethical conduct

• Proficiency with standard business software tools (e.g. MS Word Excel PowerPoint Adobe)

Work Environment

• Fastpaced collaborative biotechnology environment

• Requires flexibility adaptability and a proactive solutionoriented mindset

• Minimal daytoday supervision with high expectations for independent judgment and initiative

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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 jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.