Manager, Specialty Care, Global Regulatory Affairs
Site Name: RTP Posted Date: May 10 2021 Are you interested in a highly visible regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Manager, Therapeutic Group, Global Regulatory Affairs position could be an ideal opportunity to explore. As the Manager, Therapeutic Group, Global Regulatory Affairs, you will be responsible to: Ensure the development of appropriate regional regulatory strategy(ies) and their execution for assigned asset(s) consistent with the 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. This role will provide YOU the opportunity to lead key activities to progress YOUR career; these responsibilities include some of the following: Accountable to the Global Regulatory Lead and Global Regulatory TA Head for development of appropriate regional regulatory strategy(ies) 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: · 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(ies) 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 lifecycle. Why You? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor degree in biological or healthcare science Experience in all phases of the drug development process in regulatory affairs Minimum of three years prior experience in regulatory affairs Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree or PhD in biological or healthcare science Capable of leading regional development, submission and approval activities in local region(s) 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 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 *This is a job description to aide in the job posting, but does not include all job evaluation details. 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