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Global Regulatory Strategy Director, Precision Medicine and Digital Health

vor 2 Monaten


Zug, Zug, Schweiz 1925 GlaxoSmithKline LLC Vollzeit
About the Role

We are seeking a highly skilled and experienced Associate Director to lead our Global Regulatory Affairs team in the area of Precision Medicine and Digital Health. As a key member of our team, you will be responsible for developing and executing regulatory strategies to support the development and approval of precision medicine and digital health products across our therapeutic portfolio.

Key Responsibilities
  • Develop and execute global regulatory strategies for precision medicine and digital health products, ensuring compliance with regional regulatory requirements and internal GSK processes.
  • Lead interactions with local and regional regulatory authorities, ensuring effective communication and collaboration.
  • Collaborate with cross-functional teams, including Experimental Medicine Unit and Digital Health teams, to ensure alignment and effective 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, ensuring effective communication and stakeholder management.
  • Provide assessment of precision medicine and digital health components for potential in-license molecules, ensuring alignment with GSK's business objectives.
Requirements
  • BS in biological science, healthcare science, or engineering.
  • Experience in regulation of companion diagnostics and SaMD within a pharmaceutical company.
  • Proven track record of leading global development, submission, and approval activities, with experience in milestone meetings and clinical trial requirements.
  • Experience with licensing requirements for precision medicine and digital health products in all major countries.
Preferred Qualifications
  • Excellent communication skills, with proven ability to deliver key messages with clarity, impact, and passion.
  • Proven ability to build strong personal networks within GSK and use them to secure support and outcomes for projects.
  • Ability to recognize and resolve conflict, and arbitrate as necessary, ensuring successful outcomes.
  • Proven ability to take sound decisions, often without complete information, and balance the expectations of agencies and ensure compliance with regulation in all regions.
About GSK

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).

We are an equal opportunity employer and adhere to affirmative action principles, ensuring that all qualified applicants receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.