Associate Director, Global Regulatory Affairs, Precision Medicine
Vor 3 Tagen
Client: 1925 GlaxoSmithKline LLC
Location: Zug
Job Reference: 5c4cbd6620c7
Job Views: 8
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:Purpose:
Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achieved as a component of an overall global regulatory approach and ensure compliance with both internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.
Responsibilities and Accountabilities:
- The Associate Director will be accountable to the GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery.
- Planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with Precision Medicine/Digital Health partners and regulatory agencies.
- This role works closely with members of the Experimental Medicine Unit and Digital Health teams.
- Lead or participate in interactions with local / regional regulatory authorities.
- Ensure the development of appropriate global Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio.
- Leading regulatory interactions and the review processes for GSK.
- Ensuring compliance with regulatory requirements at all stages of product life from C2MD.
- Advocate persuasively approaches to senior leaders in GSK and in Health Authorities.
- Provide assessment of Precision Medicine and Digital Health components leveraged for potential in-license molecules.
Competencies and Capabilities:
Challenges and questions ways of working to seek improved process. Establishes team goals and uses to seek to improve performance, with ability to set challenging but realistic targets.
Basic Qualifications:
- BS in biological science, healthcare science, or engineering.
- Experience in regulation of companion diagnostics and SaMD within a pharmaceutical company.
- 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.
Preferred Qualifications:
- Excellent communication skills, ideally in writing and verbally.
- Proven ability to deliver key communication with clarity, impact and passion.
- Ability to foster strong matrix working and facilitate groups to create solutions.
- Ability to lead change and communicate difficult messages.
- Proven ability to build strong personal networks within GSK and develop an external network.
- Ability to proactively recognize and resolve conflict and arbitrate as necessary.
- Proven ability to derive creative solutions to regulatory problems.
- Proven ability to take sound decisions, often without complete information.
Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles.
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Zug, Schweiz TN Switzerland VollzeitDirector, Global Regulatory Affairs, Precision Medicine & Digital Health, ZugClient: 1925 GlaxoSmithKline LLCLocation: ZugJob Reference: ff5fb170779dJob Views: 14Posted: 22.01.2025Expiry Date: 08.03.2025Job Description:Purpose:Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned...
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Zug, Schweiz 1925 GlaxoSmithKline LLC VollzeitPurpose Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both...
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Zug, Schweiz 1925 GlaxoSmithKline LLC VollzeitPurpose Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both...
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