Director of Regulatory Affairs and Precision Medicine Strategy
2 weeks ago
Develop and execute a regional regulatory strategy for precision medicine and digital health assets, ensuring compliance with internal GSK processes and regional regulatory requirements. This role requires collaboration with global regulatory science and precision medicine teams, as well as regional regulatory affiliates.
Responsibilities and AccountabilitiesAccountable for developing and delivering regional regulatory strategies for precision medicine and digital health assets, working closely with the global regulatory science and precision medicine teams. Key responsibilities include:
- Leading regulatory interactions and review processes for GSK.
- Ensuring compliance with regulatory requirements at all stages of product life, from C2MD.
- Advocating for regulatory approaches to senior leaders in GSK and health authorities.
- Providing assessments of precision medicine and digital health components for potential in-license molecules.
Required qualifications include a bachelor's degree in biological or healthcare science, extensive experience in regulatory considerations for companion diagnostics and/or SaMD, and experience with clinical trial and licensing requirements for precision medicine and digital health products in major countries.
Preferred qualifications include a PhD in a biological or healthcare science, excellent communication skills, and the ability to build strong personal networks within GSK and externally.
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London, Greater London, United Kingdom GSK Full timeJob DescriptionGSK is seeking a highly skilled and experienced professional to lead our regulatory affairs and precision medicine efforts. As Director of Regulatory Affairs and Precision Medicine, you will be responsible for developing and executing global regulatory strategies for precision medicine and digital health assets across our therapeutic...
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London, Greater London, United Kingdom GSK Full timeJob SummaryGSK is seeking a highly skilled Director of Policy and Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and executing regulatory strategies for precision medicine and digital health assets across our therapeutic portfolio.Key ResponsibilitiesDevelop and execute global...
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