Senior Regulatory Affairs Associate- Hepatitis
United Kingdom - Cambridge
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 exciting opportunity for a Senior Regulatory Affairs Associate in the Hepatitis team is a key position within the team.
This opportunity would allow you to strengthen your EU centralised experience in both a pre- and post- marketing setting. As part of the Hepatitis 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 you will be involved with. Each role within the team is highly visible and has a direct impact on bringing Gilead's therapeutics to patients.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Support the preparation of regulatory submissions for investigational and marketed Hepatitis medicinal products.
- For marketed Hepatitis medicinal products prepare and/or co-ordinate submissions via the EU Centralised procedure. This may include labelling variations, PSURs/RMPs, responses to questions, renewals.
- For investigational Hepatitis medicinal products prepare and co-ordinate regulatory documentation to support early phase development, including Clinical Trial Applications/ amendments and Paediatric Investigation Plans
- Interact with cross-function teams to ensure optimal execution of the agreed regulatory strategy for investigational medicinal products.
- Represent International Regulatory Affairs (Int RA) function at cross functional submission/study management team meetings.
- Assist 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 Hepatitis team as required.
- Excellent oral and written English communication skills
- Excellent planning and organisational skills with the ability to work simultaneously on a number of 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
- 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.
EDUCATION and/or EXPERIENCE REQUIRED
- Life Science degree and demonstrated relevant regulatory affairs experience
- An understanding of regulatory requirements for the EU centralised procedure
- Experience in supporting post-approval management of variations, renewals, responses to questions, PSURs etc. for EU centralised products is desirable.
- Experience in working with document management systems
COMPANY CORE VALUES
- Teamwork, Excellence, Accountability, Integrity, Inclusion
You can be based at Stockley Park 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:
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