Director, Global Regulatory Affairs, Precision Medicine
vor 3 Wochen
Develop and execute a comprehensive regulatory strategy for Precision Medicine and Digital Health assets across the GSK therapeutic portfolio, ensuring compliance with internal processes and regional regulatory requirements.
Responsibilities and Accountabilities- Lead the development of global regulatory strategies for Precision Medicine and Digital Health assets, ensuring timely delivery and compliance with regulatory requirements.
- Collaborate with cross-functional teams to ensure alignment and effective execution of regulatory strategies.
- Represent GSK in interactions with regulatory agencies and partners, advocating for regulatory approaches and ensuring compliance with regulations.
- Provide regulatory expertise and guidance to support the development and approval of Precision Medicine and Digital Health products.
- Ensure compliance with regulatory requirements at all stages of product life, from C2MD to commercialization.
- Challenges and questions ways of working to seek improved processes.
- Establishes team goals and uses them to seek to improve performance, with ability to set challenging but realistic targets.
- Master's Degree in biological science, healthcare science, or engineering.
- Experience in regulation of companion diagnostics and SaMD.
- Led global development, submission, and approval activities. Organized and executed milestone meetings.
- Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in all major countries.
- Excellent communication skills, ideally in writing and verbally. Proven ability to deliver key communication with clarity, impact and passion.
- Proven ability to foster strong matrix working. Capable of facilitating groups of individuals to work together on creating solutions.
- Ability to lead change and communicate difficult messages. Able to implement plans and hold self and team accountable for delivery of short and medium term goals.
- Proven ability to build strong personal networks, within GSK and use them to secure appropriate support and outcome for a project, developing an external network.
- Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome.
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Director, Global Regulatory Affairs, Precision Medicine
vor 2 Monaten
Zug, Zug, Schweiz 1925 GlaxoSmithKline LLC VollzeitAbout the RoleWe 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...
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