Regulatory Affairs Manager Oncology & Anti-infectives
United 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.
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 to join the Oncology and Anti-infectives team, which provides leadership and support for the development of Gilead's growing product portfolio in the EU, UK, Australia, Canada, and Switzerland.
As part of the Oncology and Anti-infectives team you will be given opportunities to grow as a regulatory professional, and quickly expand your knowledge and experience through the diverse range of regulatory activities. Each role within the team is highly visible and has a direct impact on helping to meet the company's goal of bringing transformative medicines to patients.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Helps define the regional regulatory strategy for development or marketed products.
- Prepares and co-ordinates regulatory documentation to support early phase development, including Clinical Trial Applications, Paediatric Investigation Plans and Agency meetings.
- Interacts with cross-functional teams to ensure optimal execution of the agreed regulatory strategy for investigational medicinal products.
- Represents International Regulatory Affairs (Int RA) at cross functional submission/study management team meetings.
- Supports and potentially leads new indication applications in Gilead's core international markets comprising EU, UK, Australia, Canada, and Switzerland.
- Prepares and/or co-ordinates submissions via the EU Centralised procedure. This may include e.g., labelling variations, PSURs/RMPs, responses to questions, renewals.
- Assists in ensuring product packaging and associated information is updated and maintained in accordance with marketing authorisations, including the review and provision of accurate labelling translations.
- Responsible for maintaining a working knowledge of EU regulatory requirements and guidelines and for communicating changes in regulatory information to cross-functional teams.
- Supports the remainder of the Oncology and Anti-infectives team as required.
- Excellent oral and written English.
- Excellent planning and organisational skills with the ability to work simultaneously on several 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 and strategic thinking skills with ability to impact and influence.
- Attention to detail with accuracy and quality.
- Ability to understand and effectively relate to external and internal customers.
- Business awareness and professionalism.
EDUCATION and/or EXPERIENCE REQUIRED
- Life Science degree and demonstrated relevant regulatory affairs experience.
- Stockley Park or Cambridge.
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---Uxbridge/Regulatory-Affairs-Senior-Manager---Oncology_R0019044-1
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