Requirements: English
Company: WhatJobs
Region: Zug , Zoug
Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health, Zug
Client: 1925 GlaxoSmithKline LLC
Location: Zug
Job Reference: 5c4cbd6620c7
Job Views: 1
Posted: 08.05.2025
Expiry Date: 22.06.2025
Job Description
Purpose
Ensure the development and execution of appropriate regulatory strategies for Precision Medicine and Digital Health assets, supporting GSK''s therapeutic portfolio. The role involves aligning with global regulatory requirements, internal policies, and regional regulations to deliver optimal labeling based on available data.
Responsibilities and Accountabilities
- Develop regional and global regulatory strategies for Precision Medicine and Digital Health assets.
- Lead or participate in interactions with regulatory authorities and internal teams.
- Ensure compliance throughout the product lifecycle from C2MD.
- Advocate persuasively with senior leaders and health authorities.
- Assess in-licensing opportunities involving Precision Medicine and Digital Health components.
Competencies and Capabilities
Set team goals, seek process improvements, and foster high performance. Demonstrate strong matrix working, leadership, and communication skills.
Basic Qualifications
- BS in biological sciences, healthcare sciences, or engineering.
- Experience in regulation of companion diagnostics and SaMD within pharma.
- Experience with global development, submission, approval, and milestone meetings.
- Knowledge of clinical trial and licensing requirements for relevant products worldwide.
Preferred Qualifications
- Excellent communication and leadership skills.
- Strong networking and conflict resolution abilities.
- Creative problem-solving skills with a focus on compliance and regulatory expectations.
About GSK
GSK is a global biopharma dedicated to uniting science, technology, and talent to combat disease. We focus on vaccines, medicines, and innovative therapies in infectious diseases, HIV, respiratory/immunology, and oncology. We value an inclusive environment where employees can thrive and grow.
GSK is an Equal Opportunity Employer and adheres to Affirmative Action principles in the US.
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