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Regional Head Regulatory Affairs
3 months ago
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.
regulatory affairs; regulatory strategy; vaccines; infectious disease;