Associate Director, Global Regulatory Affairs, Precision Medicine

vor 1 Monat


Zug, Zug, Schweiz 1925 GlaxoSmithKline LLC Vollzeit
Job Title:

Associate Director, Global Regulatory Affairs, Precision Medicine

Job Summary:

We are seeking an experienced Associate Director to lead our Global Regulatory Affairs team in the development of Precision Medicine strategies. The successful candidate will have a strong background in regulatory affairs and experience in leading global teams. The role will involve working closely with cross-functional teams to develop and execute regulatory strategies for Precision Medicine products.

Main Responsibilities:
  1. Lead the development and execution of global regulatory strategies for Precision Medicine products.
  2. Collaborate with cross-functional teams to ensure regulatory compliance and strategy alignment.
  3. Develop and maintain relationships with regulatory agencies and partners.
  4. Provide regulatory guidance and support to teams.
Requirements:
  • 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.
  • 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.
  • Commands attention and interest through use of appropriate communication techniques.


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