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Regulatory Affairs Director

2 months ago

London, Greater London, United Kingdom GlaxoSmithKline Full time
Job Title: Regulatory Affairs Director

GlaxoSmithKline is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and executing regulatory strategies for precision medicine and digital health assets across our global portfolio.

Key Responsibilities:
  • Develop and execute global regulatory strategies for precision medicine and digital health assets
  • Ensure compliance with regulatory requirements at all stages of product life
  • Lead regulatory interactions and review processes for GSK
  • Collaborate with regional regulatory affiliates to create a regional collaboration framework for precision medicine and digital technologies
Requirements:
  • Bachelor's degree in biological or healthcare science
  • Extensive experience in regulatory consideration for all phases of companion diagnostics and/or SaMD
  • Experience leading global development, submission, and approval activities (FDA)
  • Ability to organize and execute successful milestone meetings and build strong relationships with health authorities
Preferred Qualifications:
  • PhD in a biological or healthcare science
  • Excellent communication skills and ability to deliver key messages with clarity and impact
  • Proven ability to build strong personal networks and derive creative solutions to regulatory problems
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 welcome applications from all qualified candidates. We believe in an agile working culture for all our roles and offer a range of benefits to support your career and wellbeing.