Regulatory Affairs, Senior Associate (HIV)

Gilead Sciences, Inc. ,
Uxbridge, Greater London
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**For Current Gilead Employees and Contractors:** Please log onto your Internal Career Site at to apply for this job. **Job Description** A career within Gilead's lean, fast paced International HIV regulatory team will give you the opportunity to grow as regulatory professional, expanding your knowledge and experience quickly. Working with an experienced team of regulatory leaders each role within the team is highly visible and has a direct impact on bringing Gilead's therapeutics to patients quickly. We have an exciting opportunity for a Senior Regulatory Affairs Associate in the HIV team. This role can be based at Stockley Park or Cambridge office. **ESSENTIAL DUTIES AND RESPONSIBILITIES** include the following: 1. 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. 2. Preparation and/or coordination of regulatory labeling variation submissions for Gilead's marketed products in line with corporate objectives. 3. Assist in ensuring product packaging and associated information is updated and maintained in accordance with product licences' in international territories including the review and provision of accurate labelling translations. 4. Support the preparation/ maintenance of clinical trial applications, ROW core dossiers and response to ROW questions. 5. Represents International Regulatory Affairs (International RA) function at cross functional submission/ study management team meetings. 6. Participate in regulatory HIV team meetings, product team meetings and departmental meetings. 7. Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies. 8. Support the HIV International RA team as required. **COMPANY CORE VALUES** Teamwork, Excellence, Accountability, Integrity, Inclusion **CORE COMPETENCIES** 1. Excellent oral and written English communication skills 2. Excellent planning and organizational skills with the ability to work simultaneously on a number of projects with tight timelines 3. Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills. 4. Planning and information seeking skills and ability to work on specific tasks with minimal supervision. 5. Problem solving, strategic thinking skills with ability to impact and influence 6. Attention to detail with accuracy and quality 7. Ability to understand and effectively relate to external and internal customers 8. Business awareness and professionalism **KEY ROLE-RELATED COMPETENCIES** 1 Able to facilitate/impact and influence effective planning interactions and discussions 2 Able to effectively interact with external parties to information gather and effectively drive projects through to completion to tight timelines. 3 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-licensing management of variations, renewals, responses to questions, Follow-up Measures, PSURs etc for Centralized products is desirable. Experience with working with document management systems (RDMS / SIMS). **TRAVEL** Very limited European travel may be required. **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 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 disease

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