Director, Regulatory Affairs, Precision Medicine Digital Health

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Job Purpose Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data and in the global regulatory context.   Responsibilities and Accountabilities   Accountable to GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. In this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level. This role works closely with members of the Precision Medicine and Digital Health teams. This role will also have significant collaboration with the regional regulatory affiliates in the creation of a regional collaboration framework for Precision Medicine & Digital Technologies.   In performing the role, the job holder will be responsible for: • Ensure the development of appropriate global Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. Leading regulatory interactions and the review processes for GSK. • Ensuring compliance with regulatory requirements at all stages of product life from C2MD. • Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities. • Capable of providing assessment of Precision Medicine and Digital Health components leveraged for potential in-license molecules.   Why you?   Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: • Bachelor’s degree in biological or healthcare science. • 5+ years experience in regulatory consideration for all phases of the companion diagnostics and/or SaMD, including for projects with little or no precedence. • Experience of leading global development, submission and approval activities (FDA). • Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority, additional experience ex US and EU preferred. • Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in major countries and ideally sound knowledge globally.   Preferred Qualifications: If you have the following characteristics, it would be a plus: • PhD in a biological or healthcare science. • Excellent communication skills, ideally in writing and verbally. Proven ability to deliver key communication with clarity, impact and passion. Commands attention and interest through use of appropriate communication techniques. Proven ability to foster strong m