Associate Director, Regulatory Affairs- Oncology
Associate Director, Regulatory Affairs- Oncology
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 driven individual who is passionate about bringing transformational medicines to those with continued unmet medical need.
This is an exciting opportunity for a Regulatory Affairs Associate Director to join the Gilead Global Regulatory Affairs Oncology team to support drug development. The role encompasses providing regulatory strategy, leadership, and operational support for Gilead's growing oncology development product portfolio, allowing you to strengthen your drug development and regulatory expertise.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Defining the regional regulatory strategy for development or marketed products in conjunction with regional director
- Interacting with the Global Regulatory Leads to agree and ensure delivery of the local regulatory strategy
- Striving to ensure direct reports learn and develop aspects of regulatory strategy and research, to lead or contribute to regional strategies
- Leading new indication and marketing applications in Gilead's core international markets comprising EU, UK, Switzerland, Australia and Canada
- Acting as representative for specific indications at Regulatory Project Team for specified regions and products
- Being responsible for the preparation of moderately complex regulatory submissions which require interaction with cross-functional teams to ensure optimal execution
- Ensuring regional product labelling is created and maintained in alignment with the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI)
- 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.
- Problem solving, strategic thinking skills with ability to impact and influence
- Experience in developing and implementing regulatory strategy
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
EDUCATION and/or EXPERIENCE REQUIRED
- Life Science degree and demonstrated relevant regulatory affairs experience
- Good knowledge of regulatory affairs across the European region
COMPANY CORE VALUES
- Teamwork, Excellence, Accountability, Integrity, Inclusion
UK, at the Stockley Park (Greater London) or 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/Associate-Director--Regulatory-Affairs--Oncology_R0022614-1
Copyright 2021 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency