Director, Regulatory Affairs, Precision Medicine Digital Health
Core
Develop and execute global regulatory strategies for Precision Medicine and Digital Health assets, ensuring compliance across the product lifecycle from C2MD.
Role type
Director, Regulatory Strategy
Builds
Global regulatory strategies and submission plans for precision medicine and digital health products
Domain
Biopharmaceuticals, Precision Medicine, Digital Health (SaMD, Companion Diagnostics)
Required skills
Global regulatory strategy, FDA submission leadership, Health Authority relationship management, Clinical trial and licensing requirements, In-license assessment, Matrix leadership
Preferred skills
PhD in biological/healthcare science, Advanced communication and stakeholder management, Conflict resolution, Creative problem solving under uncertainty
Technologies
None stated
Responsibilities
Lead regulatory interactions and review processes for GSK; Ensure compliance with regulatory requirements at all stages of product life; Advocate approaches to senior leaders and Health Authorities; Assess Precision Medicine and Digital Health components for potential in-license molecules
Seniority
Director, strategic planning and matrix leadership