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GlaxoSmithKline LLC Manager/Associate Director, Global Regulatory Affairs, Oncology in Collegeville, Pennsylvania

Reference #: 280183Site Name: USA - Pennsylvania - Upper ProvidencePosted Date: Feb 19 2021We're seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our CMC Regulatory Affairs Group. Are you an experienced CMC RA professional looking to advance in your career? If so, this Manager/Associate Director, Global Regulatory Affairs, Oncology role may be an ideal opportunity to explore!This position will ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work closely with local / regional commercial team to secure best possible labeling commensurate with the available data. Lead interactions with local / regional regulatory authorities. In performing the role, the job holder will be responsible for:This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globallyImplementation of the regional strategy(s) in support of the project globallyLead regulatory interactions and the review processes in local regionEnsuring appropriate interaction with regional commercial teams in local regionEnsuring compliance with regional requirements at all stages of product life from C2MDWhy You?Basic Qualifications:Bachelors degree in biological or healthcare scienceExperience of all phases of the drug development process in regulatory affairs,Experience leading regional development, submission and approval activities in local region(s)Preferred Qualifications:Advanced degree or PhD in biological or healthcare scienceExtensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.Knowledge of relevant area of medicine, and ability to further develop necessary specialist knowledge for the product or area of medicineGood communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passionAbility to foster strong matrix working.Developing personal networks, within GSK and capable of using them to secure appropriate support and outcome for a project.Capable of identifying project or team issues in advance and seeking necessary help and support to resolve. Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognises potential long term issues for projects.Ability to take sound decisions In doing so, the job holder will use a range of sources and weight benefits and risks before making important decisions.Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Seeks to raise levels of performance by establishing or improving processWhy GSK?Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation,

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