Location: Remote Head Office across Africa

Hours: Full-time

Reports to: CEO/CMO- Africa Clinical Research Network

Salary: $55,000 pa (USD) in local currency, dependent on experience

Our Mission:
The Ellison Institute of Technology (EIT) works to develop and deploy advanced technology in pursuit of solving some of humanity’s most challenging and enduring problems. Guided by world leaders, scientists, and entrepreneurs, EIT seeks to accelerate innovation by driving scientific and technological advancements across four humane endeavours: health and medical science, food security and sustainable agriculture, climate change and clean energy, and government innovation and era of artificial intelligence.

Please visit eit.org for more details.

At the Ellison Institute, we believe that an inclusive, collaborative team atmosphere is just as important to our mission as our scientific aims and methods. We strive to build a supportive environment where everyone feels confident taking creative risks toward innovation. We value emotional intelligence and communicating with empathy and respect for others. We foster a team that is curious, has a deep sense of commitment, responsibility, and the resilience needed to achieve excellence.

Job Summary:
We are establishing a clinical research network and are on a mission to revolutionise clinical research in Africa. Our vision is to build a sustainable, African-led research ecosystem that drives health equity and innovation. By establishing a network of world-class clinical research sites and capabilities, we aim to generate the evidence Africa needs to inform health decisions and policies, while cultivating the next generation of African scientific leaders.

Africa has been underrepresented in global clinical research, conducting only 2% of clinical research despite shouldering 25% of the world's disease burden. While there have been significant investments in disease-specific clinical research sites and networks, these approaches have often led to fragmented infrastructure, limited capacity, and reliance on expatriate leadership. Such models have struggled to drive long-term sustainability or meet the broader health needs of African countries and regions beyond narrow therapeutic areas. Consequently, health products and policies in Africa are often informed by data from other settings, which may not fully account for the rich diversity of African populations and local contexts. This lack of locally relevant evidence hinders the development of tailored health solutions that effectively address Africa's unique challenges and priorities.

Our clinical research network is on a mission to transform this landscape. By partnering with leading institutions and trial units across the continent, we will establish a network of clinical research sites that serve two critical goals: diversifying global research and empowering Africa to meet the healthcare needs of its rapidly growing population.

Our network will be designed to catalyze Africa's self-sufficiency in pharmaceutical and vaccine R&D and manufacturing, ensuring the continent can drive its own health innovation agenda. We will establish digital and clinical infrastructure, while prioritizing deep community engagement to foster trust, relevance and impact.

At our sites, we will conduct rigorous, ethical research that puts African populations and priorities at the centre. By generating high-quality local data that reflects the diversity of African contexts, we can accelerate the development and delivery of tailored global health solutions - for Africa, by Africa. Our goal is to build sustainable research capacity that outlasts any single study or funder, empowering African institutions to become global leaders in clinical research and scientific innovation for generations to come.

Overview:
We are seeking a highly experienced Head of Regulatory Advocacy & Market Access with a background in the pharmaceutical industry to lead our regulatory strategy and advocacy efforts. This key leadership role will involve engagement with national and international regulatory bodies, ethics boards, and market access stakeholders. The successful candidate will develop and execute strategies to navigate regulatory environments, promote policy frameworks, and secure market access for pharmaceutical products.

Key Responsibilities:
Regulatory Advocacy & Policy Development:
Lead the development and implementation of regulatory advocacy strategies aimed at influencing policy and decision-making within National Regulatory Authorities (NRA) and National Ethics Committees (NEC).
Engage with policymakers, Ministry of Health (MoH) officials, and regulatory authorities to advocate for favorable regulations that support market access.
Monitor legislative and regulatory developments to ensure alignment with evolving healthcare policies and global regulatory requirements.

National Ethics Boards & Regulatory Engagement:
Establish and maintain strong relationships with National Ethics Boards and NRA to facilitate the approval of clinical trials and new pharmaceutical products.
Serve as the company's representative in meetings with ethics boards, ensuring adherence to ethical guidelines and prompt resolution of regulatory concerns.
Advocate for streamlined submission processes and ethical approval pathways that align with international standards.

Submission and Licensing Requirements:
Oversee the preparation, submission, and approval of regulatory submissions to ensure compliance with local and international regulations.
Ensure timely submission of documentation for licensing, renewals, and post-marketing surveillance for pharmaceutical products.
Lead the development of robust regulatory strategies to accelerate approvals for market access in new and existing markets.

Market Access & Policy Framework Development:
Lead efforts to develop policy frameworks that promote access to medicines through NRA and NEC collaborations.
Develop strategies for data sharing agreements that facilitate efficient regulatory approvals and product registrations across borders.
Advocate for policy changes that support broader access to pharmaceutical innovations, addressing regulatory hurdles that may hinder product entry into key markets.
Networking and Stakeholder Engagement:
Build and maintain strategic partnerships with pharmaceutical companies, regulatory bodies, MoH, healthcare providers, and key industry stakeholders to support advocacy efforts.
Represent the company at industry forums, regulatory conferences, and advocacy groups to ensure strong networks and influence within the regulatory landscape.
Collaborate with internal and external stakeholders to gather insights and develop a proactive approach to regulatory engagement.

Compliance and Ethical Governance:
Ensure all regulatory activities comply with national and international legal, ethical, and compliance standards.
Monitor internal compliance with regulatory obligations, ensuring that all submissions and interactions with authorities are conducted ethically and transparently.
Work closely with internal teams to ensure that the company is fully compliant with evolving regulatory frameworks and legal requirements.

Qualifications:
Education: Bachelor’s degree in Pharmacy, Life Sciences, or a related field (required).
Advanced degree (Master’s or PhD) in Regulatory Affairs, Pharmaceutical Sciences, or a related discipline is preferred.

Experience:
Minimum of 7-10 years of experience in pharmaceutical regulatory affairs or market access roles, with a strong background in regulatory submissions and policy advocacy.
Proven experience engaging with National Regulatory Authorities (NRA), National Ethics Committees (NEC), and Ministry of Health (MoH) officials.
Experience in navigating submission requirements, licensing, and regulatory policy development for pharmaceutical products.

Skills and Competencies:
Strong understanding of regulatory frameworks, submission processes, and ethical guidelines in the pharmaceutical industry.
Proven ability to build relationships and engage with government bodies, regulatory authorities, and industry stakeholders.
Excellent communication and negotiation skills, with the ability to influence regulatory policy and advocate for favorable outcomes.
Strong leadership and project management skills, with experience leading cross-functional teams.

Desired Attributes:
Strategic thinker with a proactive approach to solving complex regulatory and market access challenges.
Ability to adapt to a dynamic regulatory environment and influence stakeholders in a professional and ethical manner.
Demonstrated ability to lead advocacy initiatives, regulatory submissions, and manage multiple projects simultaneously.

Work Environment:
The Head of Regulatory Advocacy & Market Access will be remote based, with occasional travel required for regulatory meetings, industry conferences, and engagement with external stakeholders.

Head of Regulatory Advocacy & Market Access - (African based)

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