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Regional Head Regulatory Affairs

3 months ago

London, United Kingdom i-Pharm Consulting Full time

Wanting to make a difference in the world of global health utilising your vaccine development experience?

We are seeking applications for the position of Head of Regulatory Affairs for a regional leadership role for the APAC markets. Working at the forefront of vaccine development programs, our client is a global health group on a mission

Responsibilities;

Regional engagement;

  • Act as the Regulatory Affairs Asia Pacific Centre of Excellence for the Asia Pacific region
  • Establish relationships with key Asia Pacific regional and local regulatory authorities
  • Develop stakeholder map covering internal and external stakeholders and organisations
  • Partner with regulators in the Asia Pacific region and influence content on emerging regulatory guidance
  • Collect, share and interpret emerging regulatory guidance from different regional / country-level regulatory authorities
  • Drive regulatory harmonization through innovative regulatory sciences - collaboration with other internal functions.
  • Develop regional regulatory strategy aligned with mission objectives

Vaccine Development Projects:

  • Provide global regulatory support, advice and guidance to development projects, including preparation for meetings with regulatory authorities
  • Line manage and assign projects to regulatory affairs staff and consultants (as required) to ensure that the regulatory resource requirements to projects are managed in an effective way
  • Develop internal partnership with key R&D departments

Who we are looking for:

This position would require previous working experience of supporting vaccine development programs, strong regulatory strategy development/implementation and a desire to work in the Global Health landscape.

We are seeking a minimum 10 years of experience in a regional and or global regulatory affairs leadership role in pharmaceutical or biotechnology industries, not-for-profit or regulatory agency.

This is a remote working opportunity.

Desired Skills and Experience

regulatory affairs; regulatory strategy; vaccines; infectious disease;