Senior Regulatory Affairs Manager

Description:

Purpose of the role:

To develop CEPI regulatory strategies and execution plans for Africa that are aligned with the CEPI portfolio and execute the plans in partnerships with key regional and local regulatory authorities, institutions / initiatives and other partners to enhance regional and country epidemic / pandemic preparedness.

Key tasks and responsibilities

· Assist with generation and adaptation of global/regional regulatory strategies and harmonisation initiatives

· Develop and execute or support CEPI’s or African institutions’ regional/country readiness initiatives, including contributions to the African Medicines Agency operationalisation efforts

· Partner with affected regional bodies/country regulators and influence content of emerging regulatory guidance

· Collect, share and interpret regulatory guidance from different regional / country-level regulatory authorities

· Establish functioning working relationships with key regional and local regulatory authorities and ethics committees in Africa and with partner organisations

· Develop regulatory ecosystem map for CEPI targeted key countries in Africa

· Drive regulatory harmonization through innovative regulatory sciences in collaboration with other CEPI functions.

· As required, provide global regulatory support, advice and guidance to CEPI funded vaccine development or enabling projects, including preparation for meetings with regulatory authorities

Desired background:

· Minimum 3-5 years of experience in a regional and/or global regulatory affairs role in pharmaceutical or biotechnology industries, not-for-profit or regulatory agencies.

· Broad knowledge of the regulatory environment in the Africa region.

· Experience in building networks and relationships with health authorities.

· Demonstrated competencies of strategic work and innovation.

· Strong knowledge of regulatory affairs and development in vaccines.

· Understands the vaccine development processes and strategies for development programmes.

· Strong networking and relationship management skills.

· Proficiency in English is a must. Additional language skills (e.g., French or Portuguese) is highly desirable

· Outstanding presentation, written and oral communication skills paired with being a clear communicator with ability to influence effectively both internally and externally.

· Experience of working in an international matrix organisation is desirable

Educational Requirements

· Degree in a health science related discipline (advanced degree preferred).

Location: Desirable to be based in countries with CEPI Sites: UK/Norway/USA but other locations can be considered.

All application information will be treated in strict confidence.