Senior Manager, CMC Regulatory Affairs (MENA)
United Kingdom - CambridgeNetherlands - Hoofddorp
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
['As Senior Manager, CMC Regulatory Affairs Gulf/North Africa
you will be either based in Hoofddorp, the Netherlands or in Cambridge, UK. As part Kite's international CMC Regulatory Affairs team, you will lead the delivery of CMC Quality components for clinical trial applications, marketing applications and post-authorisation submissions Rest of World (RoW) countries with special focus on the Gulf/North African markets.
Kite, A Gilead Company
At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day - discoveries that include our own capabilities and our individual potential.
We're currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
You will be reporting to the Director Regulatory Affairs (who is based in the EU, Hoofddorp office).In this role you will:
- Actively work on submissions to:
- Ensure compliance of the CMC dossier meeting content and strategic requirements, as well as the specific local requirements of individual countries.
- Pro-actively stay current with registration requirements in each of the applicable markets, and communicate this information to the corporation on a timely basis.
- Contribute to and complete final review for all major and/or critical CMC submissions from marketing authorization application to post approval submissions, CMC briefing documents, requests for Scientific Advice, Drug Product Listings and Site licenses as appropriate) and CMC responses to Health Authorities
- Ensure appropriate content and preparation of Module 1 components per market
- Finalize CMC submission plans
- Ensure alignment of CMC submission plans with Commercial, Clinical & IP
- Be a key part of clear, concise timely communication:
- Take a leadership role in updating the corporation on local or pan-regional CMC regulatory guidance and developments
- Facilitate good communication and transparency of CMC information to relevant functions
- Use industry network to maintain awareness of the pulse of global and local CMC best practices, and to disseminate this information to the corporation.
- Ensure cross-regional communication and transparency in the flow of CMC information that may affect regional regulatory strategy
- Elevate CMC issues and potential risks, along with possible resolutions, to senior management especially when such issues impact the approvability of submissions and/or product launch
- Work as part of a global, interdepartmental team:
- Regional lead on project and other teams in developing global CMC regulatory and change control policies and strategies
- Provide consistent, high-quality input on CMC issues and risks along with mitigation plans/options.
- Local Presence:
- Build an integrated, cross functional network within market Gilead/Kite colleagues
- Responsible for ensuring timely discussion with Health Authorities as needed in collaboration with contract organization and/or local colleagues regarding responses to questions,
- Will work with global colleagues to ensure consistency of responses to international Health Authorities.
- Regulatory Strategy
- Coordinate and contribute to the development of the regional Regulatory CMC strategy, CMC submission content and timing to ensure alignment as outlined in the global regulatory strategy document.
- Develop CMC lifecycle management plans with input from regulatory project teams
- Define and highlight regional/global Regulatory CMC resource issues that may affect the implementation of the Regulatory CMC strategy
- Contribute to the creation of an integrated global Regulatory CMC strategy. Regional Regulatory CMC personnel are responsible for the definition of an appropriate regional regulatory strategy which is consistent with the global regulatory strategy.
- Ensure that decisions on the global Regulatory CMC strategy are made following consultation and agreement with CMC Management and other key stakeholders.
- Ensure that the strategy for meetings with regional regulatory authorities is consistent with the global regulatory strategy.
- MS with biologics experience.
- Significant experience in Regulatory Affairs, CMC or equivalent, relevant experience
- Direct experience working with regional CMC reviewers in ROW markets
- Excellent English written and oral communication skills
- Detail oriented, self-motivated, independent and quick to adapt to changes
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don't miss out on this opportunity to join us and discover your sense of purpose.
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.
'] To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-Kingdom---Cambridge/Associate-Director--CMC-Regulatory-Affairs--MENA-_R0020689
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