Regulatory Affairs Director
4 weeks ago
Purpose
Develop and execute regional Precision Medicine and Digital Health regulatory strategies to support GSK's therapeutic portfolio. Ensure compliance with internal processes and regional regulatory requirements to deliver optimal labeling.
Responsibilities and Accountabilities
Lead the development of regional Precision Medicine and Digital Health regulatory strategies and their timely delivery. Collaborate with the Precision Medicine and Digital Health teams and regional regulatory affiliates to create a regional collaboration framework.
Key Responsibilities:
- Develop and execute regional Precision Medicine and Digital Health regulatory strategies to support GSK's therapeutic portfolio.
- Ensure compliance with internal processes and regional regulatory requirements.
- Collaborate with the Precision Medicine and Digital Health teams and regional regulatory affiliates.
Requirements:
- Bachelor's degree in biological or healthcare science.
- Extensive experience in regulatory considerations for all phases of companion diagnostics and/or SaMD.
- Ability to advocate persuasively approaches to senior leaders in GSK and Health Authorities.
Preferred Qualifications:
- PhD in a biological or healthcare science.
- Excellent communication skills, ideally in writing and verbally.
- Proven ability to build strong personal networks within GSK and use them to secure appropriate support and outcome for a project.
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