CEPI is currently looking for a Head of Global Regulatory Affairs to join its Vaccine Research and Development (R&D) team. This will be a key role to ensure that CEPI provides effective support to developmers throughout the development of their vaccines. A critical success factor will be that you can work effectively with leafers in different organisations in a global context. We believe the right candidate has demonstrated such skills.
We are looking for candidates that are motivated by CEPI’s mission. You have minium a master’s degree in a health science related discipline, and you have minimun 5 years’ experience in a regional or global regulatory leadership role.
The role will report to the Director Vaccine R&D and is part of the Vaccine R&D Leadership Team.
Purpose of Role
The purpose of the rile is to ensure that CEPI provides effective support to developers throughout the development of their vaccines. By transforming innovative science into valued new vaccines and ensure that people around the world can access the vaccines, you influence the lives of many people.
- Lead the development and implementation of the global regulatory strategy for CEPI portfolio.
- Ensure effective cross-functional collaboration aross teams.
- Strengthen strategic parnerships with the World Health Organization (WHO).
- Engage effectively with Gavi, Wellcome and other key stakeholders.
- Influence regional and local regulatory policies for vaccines against emerging infectious diseases to enable speedly access during outbrakes.
- To oversee the end-to-end development of awardees’ vaccines from a regulatory perspectives, including quality assure clinical trial applications and to help prepare them for meetings with regulatory authorities.
- Establish effective working prosecces both internally and externally.
- Ensure proper resourcing.
Education, Experience, Knowledge and Skills
- Advance degree in health scinece related discipline.
- Minimum 5 years of experience in a regional or global regulatory leadership role in pharmaceutical or biotechnology industries or not-for-profit or regulatory agencies.
- Experience in leading major interactions with health authorities.
- Demonstrated competencies of strategic work, innovation and leadership.
- Strong knowlege of regulatory affairs in vaccines.
- Understands the vaccine development process and strategies for development programmes.
- Critical thinking on current global regulatory questions with knowledge of corresponding scientific and clinical components.
- Strong leadership skills.
- Excellent oral and written communication skills.
Travel and Location Requirements
This role will preferably be based in London (UK), although could be based in Washington D.C. (US) or Oslo (NO) for the right candidate. It will require working accross the US and Europe regulary and may require travel to other countries as projects progress.
What We can Offer You
- The opportunity to work together with leading experts on solutions for global challenges.
- Experience from the international effort of developing vaccines against emerging infectious diseases and accelerating vaccine development response to outbreaks.
- Working with global experts.
- A diverse and inclusive working environment.
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