Regulatory Affairs, Associate II- Virology
Regulatory Affairs, Associate II- Virology
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
A career within Gilead's lean, fast paced regulatory team will give you the opportunity to expand your knowledge and experience quickly. Working with an experienced team of regulatory leaders, each role within the Regulatory team is highly visible and has a direct impact on bringing Gilead's therapeutics to patients quickly.
We have an exciting opportunity for a Regulatory Affairs Associate II in the Virology team. This role will be based at our Cambridge office.
Essential Duties and Responsibilities
Support post-marketing activities for the preparation of regulatory submissions for HIV medicinal products via the EU centralised procedure, which may include, but are not restricted to variations, PSURs/RMPs, responses to questions and renewals.
Preparation and/or coordination of designated regulatory labeling variation submissions for Gilead's marketed products in line with corporate objectives.
Assist in ensuring product packaging and associated information is updated and maintained in accordance with product licences in international territories including the review of artwork for product packaging and provision of accurate labelling translations.
Support the preparation, submission, approval and maintenance (including amendments) of clinical trial applications for relevant HIV products globally, which requires close collaboration with the Affiliates, Clinical Operations staff and Contract Research Organisations.
Participate in regulatory team meetings and present project status updates.
Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.
Participate in local process improvements, which have an impact on the working of the Regulatory Affairs function.
Support the Virology Regulatory team as required.
Knowledge, Experience and Skills
Life Science degree
Relevant regulatory affairs experience (including post-marketing activities).
An understanding of regulatory requirements for the EU centralised procedure and an appreciation of current global and regional trends in Regulatory Affairs is preferable.
Excellent planning and organizational skills and the ability to work simultaneously on a number of projects with tight timelines
Excellent communication skills both in writing and verbally
Good judgment/ problem solving skills
Methodical attention to detail
Must have a professional, can-do attitude
Must be able to facilitate effective interactions within International Regulatory, as well as with other departments and sites within the Company (for example, Clinical Research and Pharmacovigilance), and Gilead affiliates and distributors
The Virology team works on a large portfolio of HIV, liver diseases and emerging viruses products and can offer the chance to work on a diverse range of regulatory activities. The team and regulatory department as a whole is built on a strong sense of team work. You will receive support from experienced regulatory professionals to expand your regulatory knowledge and progress your career.
Ability to engage and manage multiple stakeholders to achieve the objective
Curious with learning agility
Organised with systematic approach to prioritisation
Process orientated to achieve the business objective
Gilead Core Values
Integrity (always doing the right thing),
Teamwork (collaborating in good faith),
Excellence (working at a high level of commitment and capability)
Accountability (taking personal responsibility).
Inclusion (encouraging diversity)
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.
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