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UK – London – New Oxford Street, Belgium-Wavre, Poznan Grunwaldzka, Switzerland - Zug, UK - Hertfordshire - Stevenage Posted Date:
Jan 30 2025 We are seeking an Associate Director, Global Regulatory Affairs (GRA) Precision Medicine & Digital Health to ensure the development and execution of Precision Medicine and Digital Health regulatory strategies for assigned assets across GSK therapeutic portfolio. This role ensures compliance with internal GSK processes, policies, and regional regulatory requirements to deliver the best possible labelling based on available data. The successful candidate will work on a multi-year planning horizon, requiring extensive matrix collaboration within GSK up to the VP level. Additionally, this role involves representing GSK in regulatory discussions with partners and agencies, building and maintaining a robust team portfolio, and driving innovation in regulatory practices. In this role you will Ensure the development of appropriate global Precision Medicine and Digital Health regulatory strategies and their execution for assigned precision medicine and digital health assets. Lead regulatory interactions and review processes, ensuring compliance at all stages of product life from C2MD. Collaborate closely with Regulatory Operations, Precision Medicine, and Digital Health teams. Represent GSK in regulatory discussions with partners and agencies. Assess Precision Medicine and Digital Health components leveraged for potential in-license molecules. Advocate for regulatory approaches to senior leaders within GSK and Health Authorities. Basic Qualifications & Skills: BS in biological science, healthcare science, or engineering. Experience in regulation of in vitro diagnostics, companion diagnostics, and/or SaMD within a pharmaceutical company in at least one major market. Led global development, submission, and approval activities, including milestone meetings with Health Authorities. Demonstrated experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in at least one major market. Preferred Qualifications & Skills: MS or PhD in a biological science, healthcare science, or engineering. Excellent communication skills, both written and verbal, with the ability to deliver impactful messages. Proven ability to build strong personal networks and facilitate collaborative solutions. Experience in leading change, resolving conflicts, and making informed decisions under time constraints. Creative problem-solving skills with a proactive approach to regulatory challenges while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Closing Date for Applications – 13 Feb 2025 (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
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UK – London – New Oxford Street, Belgium-Wavre, Poznan Grunwaldzka, Switzerland - Zug, UK - Hertfordshire - Stevenage Posted Date:
Jan 30 2025 We are seeking an Associate Director, Global Regulatory Affairs (GRA) Precision Medicine & Digital Health to ensure the development and execution of Precision Medicine and Digital Health regulatory strategies for assigned assets across GSK therapeutic portfolio. This role ensures compliance with internal GSK processes, policies, and regional regulatory requirements to deliver the best possible labelling based on available data. The successful candidate will work on a multi-year planning horizon, requiring extensive matrix collaboration within GSK up to the VP level. Additionally, this role involves representing GSK in regulatory discussions with partners and agencies, building and maintaining a robust team portfolio, and driving innovation in regulatory practices. In this role you will Ensure the development of appropriate global Precision Medicine and Digital Health regulatory strategies and their execution for assigned precision medicine and digital health assets. Lead regulatory interactions and review processes, ensuring compliance at all stages of product life from C2MD. Collaborate closely with Regulatory Operations, Precision Medicine, and Digital Health teams. Represent GSK in regulatory discussions with partners and agencies. Assess Precision Medicine and Digital Health components leveraged for potential in-license molecules. Advocate for regulatory approaches to senior leaders within GSK and Health Authorities. Basic Qualifications & Skills: BS in biological science, healthcare science, or engineering. Experience in regulation of in vitro diagnostics, companion diagnostics, and/or SaMD within a pharmaceutical company in at least one major market. Led global development, submission, and approval activities, including milestone meetings with Health Authorities. Demonstrated experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in at least one major market. Preferred Qualifications & Skills: MS or PhD in a biological science, healthcare science, or engineering. Excellent communication skills, both written and verbal, with the ability to deliver impactful messages. Proven ability to build strong personal networks and facilitate collaborative solutions. Experience in leading change, resolving conflicts, and making informed decisions under time constraints. Creative problem-solving skills with a proactive approach to regulatory challenges while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Closing Date for Applications – 13 Feb 2025 (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
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