Regulatory Affairs Lead EMEA

Job Description

A Senior Director role based in London or Oslo

CEPI (the Coalition for Epidemic Preparedness Innovations) is a unique global organisation with a mission to stimulate and accelerate the development of vaccines against emerging infectious diseases and enable access to these vaccines for people during outbreaks. Since the outbreak of Covid-19 pandemic CEPI has also taken a leading role in fighting the pandemic by seeking to develop a vaccine against the disease.

CEPI is currently looking for a Regulatory Affairs Lead EMEA to join its Vaccine Research and Development (R&D) team. This will be a key role to ensure that CEPI provides effective support to developers throughout the development of their vaccines, and to act as the Regulatory Affairs expert for the region Europe, Middle East and Africa.

A critical success factor will be that you can work effectively with leaders 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 minimum a master’s degree in a health science related discipline, and you have minimum 5 years’ experience in a regional or global regulatory leadership role.

The role will report to the Head of Global Regulatory Affairs and is part of the Regulatory Affairs Leadership Team.

In CEPI we strive for diverse thinking, and we want diverse pools of candidates for all our vacancies. We work for an inclusive working environment where each employee can contribute and grow.

Purpose of Role The purpose of the role is to ensure that CEPI provides effective support to developers throughout the development of their vaccines and act as the EMEA Regulatory Affairs expert to progress and accomplish CEPI’s mission. By transforming innovative science into valued new vaccines and ensuring that people around the world can access the vaccines, you influence the lives of many people. Responsibilities

• Act as the Regulatory Affairs Centre of Excellence for the EMEA region and clinical development
• Provide global regulatory support, advice and guidance to CEPI funded projects, including preparation for meetings with regulatory authorities
• Ensure that the regulatory resource requirements to projects are managed in an effective way
• Partner with regulators and influence content of emerging regulatory guidance
• Collect, share and interpret emerging regulatory guidance from different regional / country-level regulatory authorities
• Develop internal partnership with key R&D departments: Clinical Development, Epidemiology, Enabling Sciences
• Regulatory representative at Clinical SWAT teams
• Establish relationships with key regional and local regulatory authorities (e.g., EMA, AVAREF etc.)
• Develop stakeholder map covering internal and external stakeholders and organisations
• Drive regulatory harmonization through innovative regulatory sciences – collaboration with other CEPI functions.

Education, Experience, Knowledge and Skills

• Degree in a health science related discipline (advanced degree preferred).
• Minimum 5 years of experience in a regional and or global regulatory affairs leadership role in pharmaceutical or biotechnology industries, not-for-profit or regulatory agencies.
• Experience in leading major interactions with health authorities.
• Demonstrated competencies of strategic work, innovation and leadership.
• Strong knowledge of regulatory affairs and development in vaccines.
• Understands the vaccine development processes and strategies for development programmes.
• Critical thinking on current global regulatory questions with knowledge of corresponding scientific components.
• Strong leadership skills.
• Excellent oral and written communication skills.

Travel and location requirements

This role can be based in London (UK) or Oslo (NO). It will require working across regions and travel to other countries as projects and initiatives progress.

What We can Offer You

• The opportunity to work together with leading experts on solutions for global challenges
• Experience from the international effort on developing vaccines against EIDs and accelerating vaccine development response to outbreaks
• Working with global experts
• A diverse and inclusive working environment

How to Apply

• If you are interested in being considered for this position, please visit https://cepi.net/careers/ to find out more and follow the “Apply Now” link.
• If you have any issues submitting your application, please contact jobs@cepi.net.

Applications must be received by 23:59 CET on 27 May 2021

About the Organization

CEPI (the Coalition for Epidemic Preparedness Innovations) is a unique global organisation with a mission to stimulate and accelerate the development of vaccines against emerging infectious diseases and enable access to these vaccines for people during outbreaks. In response tot he COVID-19 pandemic, CEPI has taken a leading role investing in multiple diverse COVID-19 vaccine candidates and co-leading COVAX alongside Gavi, the Vaccine Alliance and the World Health Organization to develop, manufacture and equitable deliver 2 billion doses of safe and effective COVID-19 vaccine by the end of 2021 to the end the acute phase of the pandemic.

In CEPI we strive for diverse thinking, and we want diverse pools of candidates for all our vacancies. We work for an inclusive working environment where each employee can contribute and grow.