Manager, Global Regulatory Affairs (Oncology)
Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham Posted Date: Nov 2 2021 We're seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our Regulatory Affairs Group. Are you an experienced RA professional looking to advance in your career? If so, this Manager, 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 globally Implementation of the regional strategy(s) in support of the project globally Lead regulatory interactions and the review processes in local region Ensuring appropriate interaction with regional commercial teams in local region Ensuring compliance with regional requirements at all stages of product life from C2MD Why You? Basic Qualifications: Bachelors degree in biological or healthcare science Two or more years experience in multiple phases of the drug development process in regulatory affairs, Two or more years experience leading regional development, submission and approval activities in local region(s) Preferred Qualifications: Advanced degree or PhD in biological or healthcare science Oncology experience preferred US regulatory experience preferred Extensive 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 medicine Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passion Ability 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 process Why GSK? Our values and expectations are 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, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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