Associate Director, Regulatory Affairs Oncology (IC & GPS)

Location
Foster City, CA, United States
Posted
Jul 04, 2021
Ref
2341848
Required Education
Bachelors Degree
Position Type
Full time
Associate Director, Regulatory Affairs 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. Gilead's 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 company's five core values. That's 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

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We are looking for a unique individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity for an Associate Director to join the Kite Pharma (Kite) Cell Therapy team, which provides leadership and support for Kite's product portfolio in the Intercontinental (IC) regions. Kite Pharma 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.

This exciting opportunity for a regulatory affairs Associate Director 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 formulating and leading complex regulatory strategies for advanced therapy medicinal products in the region; which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products. This is focused on obtaining product licenses in complex IC countries progressing to lifecycle activities and have oversight of all regulatory aspects of the application.

Provides strategic regulatory advice to global regulatory and cross functional teams as appropriate.

Partner within Kite and across Gilead Regulatory affairs, the Development and Commercial organization to lead collaborations with cross functional subject matter experts to ensure optimal execution of the agreed regulatory strategy.

Responsible for overseeing the preparation of regulatory submissions for Kite products within the designated regions and execution of agreed strategies within the IC region

To establish strong relationships and lead discussions with Kite/Gilead affiliates and distributor partners and serve as point person for knowledge for their product to these key stakeholders. Connecting Gilead affiliates with Kite cross functional teams, supporting and providing advice on Agency interaction (meetings and inspections) and support evolution/development of advanced therapy medicinal products regulation.

Continue to develop a deep and expert understanding of the regulatory environment, gathering, interpreting and ensure adherence to complex regulatory guidelines.

Responsible for overseeing and leading 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 implemented in a timely manner.

Ensures that updates to the product packaging components are implemented in line with approved labelling in line with approved labelling and agreed timelines

Leads and participates in regulatory team meetings and recognized as a knowledgeable resource for Regulatory Affairs in other departments.

Use Gilead systems for planning, preparing, tracking and storing submissions to regulatory agencies.

Line management capabilities are key including support of people development

COMPANY CORE VALUES

  • Teamwork
  • Excellence
  • Accountability
  • Integrity
  • Inclusion

    CORE COMPETENCIES
    • Direct experience in regulatory affairs in pharmaceutical industry across International markets and in regulatory submissions.
    • In depth 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, biological 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 influencing and negotiation skills
    • 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 to manage, formulate and execute strategy
    • Embrace and thrive in a diverse team
    • A driven self-starter
    • Able to lead others and take personal ownership and initiative

    EDUCATION and/or EXPERIENCE REQUIRED
    • Life Science degree.
    • Extensive 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.
    • Line management experience


    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:
    Please log onto your Internal Career Site to apply for this job.
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