Regulatory Affairs Strategist

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.

Job Description

Kite is seeking a highly motivated individual to join us as a Regulatory Strategist, Global Regulatory Affairs, to work in the exciting area of cancer immunotherapy.  This position will provide a combination of operational and strategic support within the Clinical Regulatory team of a dynamic and fast paced organization. The preferred candidate will possess strong interpersonal skills as this position interacts with all levels of employees in Clinical Operations, Clinical Development, Biostatistics, Patient Safety, Quality/Compliance, IT, and Regulatory Affairs.

Are you interested in helping ensure timely execution of clinical regulatory strategy in a cell therapy setting? Come join us in our mission to cure cancer!

RESPONSIBILITIES:

• Supports Global and Regional Regulatory Leads in execution of clinical regulatory strategy

• Completes or otherwise provides support in the preparation of routine regulatory submissions for commercial or investigational products in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, regional requirements, and scientific and company policies and procedures.

• Works closely with cross-functional team and stakeholders to ensure timely execution of core regulatory deliverables

• Performs document filing and retrieval functions in accordance with departmental standard operating procedures (SOPs).

• Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to others as needed. 

• With guidance, may participate in the development of routine labeling changes and drug listings.

• Contributes to process improvements and/or other special projects within Regulatory Affairs.

• Helps expedite and improve regulatory administrative activities by training and advising new or less experienced colleagues.

• Seeks assistance from others as needed.

• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

REQUIREMENTS:

• PharmD/PhD with some relevant experience.

• MA/MS/MBA with 2+ years’ relevant experience.

• BA/BS with 4+ years’ relevant experience.

• Extensive administrative experience in a corporate or related business work environment.

• Some regulatory, quality, compliance or related work experience supporting medicinal products.

• Experience writing or updating processes is preferred.

ADDITIONAL QULAIFICATIONS:

• Demonstrated ability to be a fast learner.

• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.

• Demonstrates sound knowledge of regulatory requirements and the role of regulatory affairs as these pertain to medicinal products, including knowledge and understanding of ICH standards and varying regional requirements in the assigned markets.

• Demonstrates strong attention-to-detail and good organizational skills.

• Demonstrates strong proficiencies in the Microsoft Office suite.

• Good project management skills, as evidenced by ability to manage multiple assignments simultaneously without compromise to timelines or quality.

• Ability to communicate in a clear and concise manner.

• Ability to support a team-oriented, highly-matrixed environment.

• Ability to execute multiple tasks as assigned.

• Knowledgeable with the drug development process, cell therapy industry, and Regulatory practices; eCTD submission experience strongly preferred

• Ability to take initiative and think critically with demonstrated troubleshooting and problem solving skills

• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment

• Comfortable negotiating and influencing in a fast-paced, dynamic, highly fluid, matrixed global organization and able to adjust workload based upon changing priorities

• Proficient in MS Word, Excel, Power Point, SharePoint and Outlook; MS Project, Documentum, document formatting tools experience a plus

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* 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 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.
 

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Gilead Sciences Inc. 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 disability, genetic 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 laws. In 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 ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.