Global Regulatory Affairs Director
2 weeks ago
We are seeking a highly skilled Global Regulatory Affairs Director to lead our Precision Medicine and Digital Health regulatory strategy. The successful candidate will be responsible for developing and executing global regulatory strategies for assigned precision medicine and digital health assets, ensuring compliance with internal GSK processes and regional regulatory requirements.
Key Responsibilities- Develop and execute global regulatory strategies for precision medicine and digital health assets
- Ensure compliance with internal GSK processes and regional regulatory requirements
- Lead regulatory interactions and review processes for GSK
- Collaborate with regional regulatory affiliates to create a regional collaboration framework for precision medicine and digital technologies
- Bachelor's degree in biological or healthcare science
- Extensive experience in regulatory consideration for all phases of companion diagnostics and/or SaMD
- Experience leading global development, submission, and approval activities (FDA)
- Strong communication and leadership skills
- PhD in a biological or healthcare science
- Excellent communication and leadership skills
- Proven ability to build strong personal networks and collaborate with cross-functional teams
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).
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