Regulatory Affairs Manager, Emerging Markets

Gilead Sciences, Inc. ,
Uxbridge, Greater London
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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 at to apply for this job. **Job Description** The way we see it, 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 fueled by a passion for improving lives of people around the world. At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where employees band together through science, grit, compassion and courage to prove the impossible wrong. We are looking for unique individuals who are passionate about advancing therapeutics throughout the emerging and developing markets. This exciting opportunity for a Regulatory Manager in the Central Support team is a key position in the team supporting territories in Asia, Latin America, Africa, Eastern Europe and/or the Middle East ESSENTIAL DUTIES AND RESPONSIBILITIES + Preparation and/or coordination of designated regulatory submissions for Gilead's marketed products in the region, in line with corporate objectives. These submissions may include, but are not restricted to, new license applications, renewals, labelling updates and variations. Liaises with Gilead's document authoring departments and product experts. + Responsible for the preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensures that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner. Liaises with Gilead affiliates and/or third parties to co-ordinate translational activities and the subsequent submission of language versions to health authorities. + Liaises with regulatory, manufacturing and other parties as appropriate, to ensure that updates to the product packaging components are implemented in line with approved labelling for new MAAs or variations affecting the labelling, and in line with required timelines, for products registered in the region. + 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 with specific country and/or regional responsibility within the region CORE COMPETENCIES + Direct experience in regulatory affairs in pharmaceutical industry across International markets and in regulatory submissions. + In depth knowledge of regulatory requirements, including ICH requirements and regional requirements. Has 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. + Excellent influencing and negotiation skills + Excellent communication skills both in writing and verbally + Methodical attention to detail + Must have a "can do" attitude and be "hands on" as and when required Location- Cambridge or Uxbridge (Stockley Park) In return of your skills and experience, you will receive a generous compensation package and join a team which supports flexible working. Join Gilead at an exciting time focused on innovation- Creating Possible drives everything we do. It's evident in our mission and core values. For us, nothing is impossible - because of the people we work with, the communities we stand with and the partners we push forward with. **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 Sit

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