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Regulatory Affairs Manager/Senior Manager Oncology MAA Support
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Position Number: 2027534
Location: Cambridge,
Position Type: Computer and Information Technology

Regulatory Affairs Manager/Senior Manager Oncology MAA Support
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

The impossible is not impossible.

It's simply what hasn't been achieved yet.

Creating Possible drives everything we do. It's evident in our mission and core values. This is how we built a culture of excellence that is fuelled by a passion for improving the lives of people around the world and advancing the care of patients suffering from life-threatening diseases worldwide.

We are looking for a unique individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity for a Regulatory Affairs Manager/Senior Manager to join the Gilead Immuno-oncology and Anti-infectives Team to directly support an EU marketing application, and potentially lead marketing applications in Gilead's core international markets, comprising Switzerland, UK, Australia and Canada.

The future of the role encompasses providing regulatory strategy, leadership, and support for Gilead's growing oncology development product portfolio, allowing you to strengthen your drug development experience in a therapeutic area driven by Gilead's desire to bring transformational medicines to those with continued unmet medical need.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

Supports an EU marketing application, and potentially lead marketing applications in Gilead's core international markets, comprising Switzerland, UK, Australia and Canada for key asset.
Helps define the regional regulatory strategy for development or marketed products.
Interacts with the Global Regulatory Leads to agree and ensure delivery of the local regulatory strategy for development 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.
Co-ordinates submissions for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Represents International Regulatory Affairs (Int RA) at cross functional submission/study management team meetings.
For investigational medicinal products, prepares and co-ordinates regulatory documentation to support early phase development, including Clinical Trial Applications/ amendments and Paediatric Investigation Plans.
Responsible for ensuring regional product labelling is created and maintained in alignment with the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI).

CORE COMPETENCIES

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.
Experience in developing and implementing regulatory strategy.
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

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.
A good scientific background and understanding with the ability to acquire this knowledge in a short timeframe.
Work is performed with limited direction of a senior Regulatory Affairs professional. Is recognized as a knowledgeable resource for Regulatory Advice on specific topics in other departments.

EDUCATION and/or EXPERIENCE REQUIRED

Life Science degree and demonstrated relevant regulatory affairs experience.
Good knowledge of regulatory requirements for the EU centralised procedure.
Experience in co-ordinating post-approval variations, renewals, responses to questions, PSURs etc. for EU centralised products is desirable.
Experience in clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials would be advantageous.
Experience in working with document management systems.

COMPANY CORE VALUES

Teamwork, Excellence, Accountability, Integrity, Inclusion.

LOCATION

Stockley Park or the Cambridge office.

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 Gilead 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/Regulatory-Affairs-Senior-Manager---Immuno-oncology-and-Anti-infectives_R0015244-1