Regulatory Affairs Manager/Senior Manager Cell Therapy / Oncology
Regulatory Affairs Manager/Senior Manager Cell Therapy / Oncology
United Kingdom - LondonUnited Kingdom - Cambridge
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
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 unique individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity for a Manager/Senior Manager to join the Kite Pharma (Kite) Cell Therapy team based on Cambridge or Stockley Park. In the 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'). Kite Pharma and the Kite 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:
- Leads all regulatory activities associated within an approved indication for ATMP, ensuring regional product labelling is created and maintained in alignment with the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI).
- Develops regulatory strategic options to support business decision making and help optimise the pathway to regulatory filings.
- Interacts with the Global Regulatory Lead to agree and ensures delivery of the regulatory strategy in ACE for both development and commercialised medicinal products.
- Acts as Regulatory Project Team representative for specified regions and 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.
- Prepares and co-ordinates regulatory documentation to support early phase development which may include Clinical Trial Applications/ amendments and Paediatric Investigation Plans.
- Represents International Regulatory Affairs (Int RA) at cross functional submission/study management team meetings.
- Responsible for maintaining a working knowledge of EU regulatory requirements and guidelines and for communicating changes in regulatory information to cross-functional teams.
- Experience in developing and implementing regulatory strategy.
- Excellent verbal and written English communication skills and demonstration of excellent interpersonal skills are required.
- 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.
- Planning and information seeking skills and ability to work on specific tasks with minimal supervision.
- 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.
- Business awareness and professionalism.
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.
- Work 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 co-ordinating post-approval variations, renewals, responses to questions, PSURs etc. for EU centralised products would be advantageous.
- Experience in regulatory activities associated with the development of medicinal products in the European Union (e.g. PIP, Scientific Advice, Orphan Drug Designation) is desirable.
- Experience in clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials is desirable.
- Good knowledge of regulatory requirements for the EU centralised procedure.
- Experience in working with document management systems.
COMPANY CORE VALUES
Teamwork, Excellence, Accountability, Integrity, Inclusion.
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:
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