Regulatory Affairs Manager (ATMP)

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, 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 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, to support development of novel advanced therapy medicinal products (ATMPs). In the role you will be responsible for developing regulatory strategy for ATMP that treat cancer and autoimmune diseases in EU and core international markets. Kite Pharma and the Kite Cell therapy regulatory team works closely with the Gilead Oncology team allowing for real time knowledge sharing and support across oncology programs.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

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

·       Prepares regulatory strategy and documentation to support Clinical Trial Applications/ amendments in the region.

·       Interacts with the Global Regulatory Lead to align on and drive  delivery of the regulatory strategy in ACE (Australia, Canada and Europe) 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.

·       Prepares and co-ordinates submissions for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.

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

·       Responsible for maintaining a working knowledge of EU regulatory requirements and guidelines and for communicating changes in regulatory information to cross-functional teams.

CORE COMPETENCIES

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

·       Strong presentation skills, with the ability to clearly articulate regulatory strategy, risks, and decision‑making rationale to cross‑functional teams.

·       Excellent planning and organisational 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 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 information gather and effectively drive projects through to completion to 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 leading the preparation and submission of regulatory documentation to support centrally approved product with post approval activities, and/or

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

·       Good breadth of understanding of the European regulations.

·       Experience in 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.

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.
 

Equal 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 individual’s 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.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.