Manager, Global Regulatory Affairs- Virology IC/GPS
- Recruiter
- Gilead Sciences, Inc.
- Location
- Cambridge
- Salary
- Competitive
- Posted
- 25 Jun 2022
- Closes
- 26 Jun 2022
- Sectors
- Engineering, Defence
- Contract Type
- Permanent
- Hours
- Full Time
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams. For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.Job DescriptionThe 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.An exciting opportunity has arisen for a Manager to join the Virology team within Global Regulatory Affairs. We are looking to hire an experienced professional who is passionate about advancing therapeutics and making a difference to the lives of patients.This role will be responsible for supporting products within the HIV and Emerging Viruses portfolio, including new product licenses and lifecycle activities of designated products in the region. The role will be responsible for leading regulatory strategies and will have oversight of all regulatory aspects of associated applications.As part of the Virology 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:Interact with the Global Regulatory Leads to ensure optimal execution of the agreed regulatory strategy for approved and investigational medicinal products within the region.Act as Regulatory Project Team representative for specified products and collaborate with cross-functional partners.Responsible for the preparation of regulatory submissions for products including maintenance of labelling and implementing updates to the Company Core Data in the therapeutic area.Establish strong relationships with Gilead affiliates and distributor partners.Participate and contribute to regulatory team meetings and be recognized as a knowledgeable resource for Regulatory Affairs in other departments.Contribute to local and / or global process improvements which have a significant impact on the business.Use internal electronic systems for planning, preparing, tracking and storing submissions to regulatory agencies.CORE COMPETENCIES Excellent verbal and written English communication skills and demonstration of excellent interpersonal skills are required.Excellent planning and organisational skills with the ability to work simultaneously on a number of projects with tight timelinesDemonstrated 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 influenceExperience in developing and implementing regulatory strategyAttention to detail with accuracy and qualityKEY ROLE-RELATED COMPETENCIESAble to facilitate/impact and influence effective planning interactions and discussionsAble to effectively interact with external parties to information gather and effectively drive projects through to completion to tight timelinesA good scientific background and understanding with the ability to acquire this knowledge in a short timeframe EDUCATION and/or EXPERIENCE REQUIREDLife Science degree and demonstrated relevant regulatory affairs experienceA good understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligenceCOMPANY CORE VALUESTeamwork, Excellence, Accountability, Integrity, InclusionLOCATIONYou 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:Please log onto your Internal Career Site to apply for this job.