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Gilead Sciences, Inc. Regulatory Affairs Associate II in Cambridge, United Kingdom

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site at https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ/cacheable-task/2997$2151.htmld to apply for this job.

Job Description

An exciting opportunity has arisen for a Regulatory Affairs Associate ll to work as a country liaison for the Intercontinental and Global Patient Solutions Team to join the International Regulatory Affairs team based in Cambridge, UK.

Essential Duties and Job Functions

This position is in the Intercontinental and Global Patient Solutions Team, and will provide regulatory support to Gilead’s activities in Latin America and the Caribbean.

The objective of this role is to maintain Gilead’s existing licenses, and support new licence applications in line with commercial priorities in the various regions.

  • Support the preparation of submissions which may include, but are not restricted to, new license applications, variations, PSURs/RMPs, responses to questions and renewals.

  • Preparation and/or coordination of designated regulatory labeling variations submissions for Gilead’s marketed products in line with corporate objectives.

  • Liaises with regulatory, manufacturing and other parties as appropriate, to ensure that product packaging and associated information is updated and maintained in accordance with product licenses in international territories.

  • Liaises directly with Gilead’s local Affiliates, distributors or agents to define/clarify submission requirements, and follow up on submissions, requests for supplementary information and approvals, in designated markets of responsibility.

  • Participates in regulatory team meetings and recognized as a knowledgeable resource of Regulatory Affairs in other departments.

  • Use internal electronic systems for planning, preparing, tracking and storing submissions to regulatory agencies.

  • Participate in routine local process improvements, which have an impact on the working of the Regulatory Affairs function.

Knowledge, Experience and Skills

  • Direct experience in Regulatory Affairs in the Pharmaceutical industry across Rest of World markets and in regulatory submissions.

  • An understanding of regulatory requirements, including ICH requirements and regional requirements and developing an appreciation of current global and regional trends in Regulatory Affairs.

  • Excellent organizational skills and ability to work on a number of projects with tight timelines, under minimal supervision.

  • Excellent communication skills both in writing and verbally.

  • Attention to detail.

  • Must have a “can do” attitude and be “hands on” as and when required.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead‎

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 at https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ/cacheable-task/2997$2151.htmld to apply for this job.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community at http://gilead.avature.net/Gilead

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