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Director, Global Regulatory Affairs, Precision Medicine
2 months ago
We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at 1925 GlaxoSmithKline LLC. As a key member of our organization, you will play a critical role in ensuring the development and execution of appropriate regulatory strategies for our precision medicine and digital health assets.
Key Responsibilities- Develop and execute global regulatory strategies for precision medicine and digital health assets, ensuring compliance with internal GSK processes and policies, as well as regional regulatory requirements.
- Lead or participate in interactions with local and regional regulatory authorities, representing GSK's interests and ensuring the best possible labeling for our products.
- Collaborate with cross-functional teams, including Experimental Medicine Unit and Digital Health teams, to ensure seamless execution of regulatory strategies.
- Ensure compliance with regulatory requirements at all stages of product life, from C2MD to commercialization.
- Advocate for regulatory approaches to senior leaders within GSK and health authorities, leveraging your expertise to drive business decisions.
- Master's degree in biological science, healthcare science, or engineering.
- Experience in regulating companion diagnostics and SaMD, with a proven track record of leading global development, submission, and approval activities.
- Strong understanding of clinical trial and licensing requirements for precision medicine and digital health products in major countries.
- Excellent communication and interpersonal skills, with the ability to facilitate matrix working and lead change initiatives.
- Proven ability to build strong personal networks and derive creative solutions to regulatory problems.
1925 GlaxoSmithKline LLC is a global biopharma company dedicated to uniting science, technology, and talent to get ahead of disease together. We are committed to making a positive impact on the health of billions of people and delivering stronger, more sustainable shareholder returns. Our success depends on our people, and we strive to create an inclusive and supportive work environment where everyone can thrive.
