Regulatory Affairs Manager – Oncology Cell Therapy

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination, and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

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 fulfill their aspirations. Join Gilead and help create possible, together.

Job Description
Kite, a Gilead company, is grounded by one common goal – curing cancer. We are at the forefront of immunotherapy and engineered T cell therapy. Our personalized approach is what sets us apart. Unlike traditional pharmaceutical manufacturing, our therapies are not created on an assembly line. With CAR T-cell therapy, we are reengineering a patient’s own immune cells to fight cancer — one patient at a time. We also are entering a pivotal time in our history with multiple planned launches and evolving competitive dynamics on a global scale. That means a fast-moving, constantly changing environment and an innovative culture, where we make discoveries every day – discoveries that include our own capabilities and our individual potential. For more information on Kite, please visit

www.kitepharma.com . Sign up to follow @KitePharma on Twitter at

www.twitter.com/kitepharma .

We are looking for a highly motivated individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity for a Manager to join the Kite Pharma (Kite) Cell Therapy team based in Cambridge or Stockley Park. In this role, you will be responsible for regulatory strategy for advanced therapy medicinal products (ATMP) that treat cancer in EU and core international markets (Switzerland, UK, Australia, and Canada, ‘ACE’ and other Intercontinental countries, ‘ICR’). Kite Pharma and the Kite Cell therapy regulatory team work closely with the Gilead Oncology team, allowing for real-time knowledge sharing and support across oncology programs.

Essential Duties and Responsibilities

Lead regulatory activities associated with development or marketed ATMP products in conjunction with regional director.

Prepare regulatory documentation to support Clinical Trial Applications/amendments in the region.

Interact with the Global Regulatory Lead to agree and ensure delivery of the regulatory strategy in ACE for both development and marketed medicinal products.

Responsible for the preparation of moderately complex regulatory submissions which require interaction with cross-functional teams to ensure optimal execution.

Prepare and coordinate submissions for assigned project(s) and territories in line with ICH requirements, regional requirements, and scientific and company policies and procedures.

Represent the Regulatory Affairs function in cross-functional teams to ensure optimal execution of the agreed regulatory strategy for both approved and development ATMPs.

Maintain a working knowledge of EU regulatory requirements and guidelines and communicate changes in regulatory information to cross-functional teams.

Core Competencies

Excellent verbal and written English communication skills and demonstration of excellent interpersonal skills.

Excellent planning and organizational skills with the ability to work simultaneously on multiple projects with tight timelines.

Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills.

Problem solving, strategic thinking skills with the ability to impact and influence.

Attention to detail with accuracy and quality.

Ability to understand and effectively relate to external and internal customers.

Key Role-Related Competencies

A good scientific background and understanding with the ability to acquire therapy area and regulatory knowledge in a short timeframe.

Able to facilitate/impact and influence effective planning interactions and discussions.

Able to effectively interact with external parties to gather information and drive projects through to completion within tight timelines.

Motivated and works independently with limited direction from a senior Regulatory Affairs professional.

Education and/or Experience Required

Life Science degree and demonstrated relevant regulatory affairs experience.

Experience in preparing and submitting regulatory documentation to support centrally approved products with post-approval activities, and/or

Experience in clinical trials applications/amendments in the European Union and a good understanding of European regulations relating to clinical trials.

Good breadth of understanding of European regulations.

Experience working with document management systems.

Experience representing Regulatory Affairs on cross-functional teams.

Company Core Values
Teamwork, Excellence, Accountability, Integrity, Inclusion.

Location
Cambridge or Stockley Park office.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates to recruit, select, and employ the most qualified persons available for positions throughout the company. All employment actions are administered on a non-discriminatory basis, regardless of protected characteristics or prohibited grounds as outlined by applicable laws.

For current Gilead employees and contractors: Please apply via the Internal Career Opportunities portal in Workday.

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