Regulatory Affairs Manager Oncology (IC & GPS)
United Kingdom - CambridgeUnited Kingdom - Uxbridge
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
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 to join the Kite Pharma (Kite) Cell Therapy team, which provides leadership and support for Kite's product portfolio in the Intercontinental (IC) region. Kite is a Gilead Company and the Kite regulatory team works closely with the Gilead Oncology team allowing for real time knowledge sharing and support across oncology programs.
Everyone at Kite 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.
This exciting opportunity for a regulatory affairs Manager would allow you to build and strengthen your knowledge in Oncology, Advanced Therapy medicinal products and the IC region. As part of the Kite team you will be given opportunities to grow as a cross functional regulatory professional through the diverse range of interactions you will have and the regulatory activities you will be involved with. This role will be based in our Cambridge or Stockley Park office.
The regulatory department is built on a strong sense of teamwork and excellence. The team is focused on brining advanced therapy medicinal products to cancer patients and can offer the opportunity to work on a diverse range of regulatory activities including strategic and technical advice from development through the product lifecycle. Core activities include planning, preparing and progressing new product registrations and subsequent post-approval safety and efficacy updates. The role involves cross-functional work with a diverse number of stakeholders both internally and externally to Gilead. ESSENTIAL DUTIES AND RESPONSIBILITIES
Responsible for preparing and submitting regulatory submissions for advance therapy medicinal products in the region. This is focused on obtaining product licenses in complex IC countries progressing to lifecycle activities.
Partner within Kite and across Gilead Regulatory Affairs, the Development, Commercial organizations and other cross functional stakeholders to ensure optimal execution of the agreed regulatory strategies.
Responsible for the preparation of regulatory submissions for Kite products within the IC region and execution of agreed strategies.
To establish strong relationships with Kite/Gilead affiliates and distributor partners and serve as point person for knowledge for their product to these key stakeholders. The person in this role will have a deep understanding of the regulatory environment leveraging internal knowledge, experience and external regulatory intelligence
Responsible for the preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensures that any updates to the Product Company Core Data Sheet (CCDS) are submitted in a timely manner.
Liaises with regulatory, manufacturing and other parties as appropriate, to ensure that updates to the product packaging components are implemented in line with approved labelling and agreed timelines.
Participates and contributes to regulatory team meetings and recognized as a knowledgeable resource for Regulatory Affairs for the wider organisation.
May participate and lead collaborative efforts across function in process improvements initiatives.
Use Gilead systems for planning, preparing, tracking and storing submissions to regulatory agencies.COMPANY CORE VALUESTeamwork Excellence Accountability Integrity Inclusion
- Direct experience in regulatory affairs in pharmaceutical industry across International markets and in regulatory submissions.
- Good knowledge of regulatory requirements, including ICH requirements and regional requirements. Has appreciation of current global and regional trends in Regulatory Affairs.
- Previous experience of working with Emerging markets, biologic products and/or in the oncology therapeutic area would be an advantage but not essential.
- Excellent organizational skills and ability to work on several projects with tight timelines.
- Excellent communication skills both in writing and verbally
- Methodical attention to detail.
- Positive and solution oriented can do attitude and be hands on as required
KEY ROLE-RELATED COMPETENCIES
- Proven track record in delivering regulatory submissions
- Embrace and thrive in a diverse team
- A driven self-starter
- Able to take ownership and initiative
EDUCATION and/or EXPERIENCE REQUIRED
- Life Science degree.
- A good level of experience in Regulatory Affairs. Direct regulatory experience with International markets is desirable.
- A proven ability to co-ordinate the preparation of a variety of complex regulatory documentation in collaboration with other functions.
About Gilead and Kite
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.
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.
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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