Head of Regulatory Affairs - Europe Cluster
Key Skills
Job Description
Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
Job Summary:
We are seeking a Head of Regulatory Affairs to join our team.
Lead and oversee all Regulatory Affairs activities across the European Union, ensuring regulatory compliance, lifecycle management, and strategic regulatory support for existing and new products. Drive regulatory strategy, manage the team of Regulatory Affairs, provide regulatory intelligence, support business development initiatives, and ensure successful execution of regulatory submissions and approvals across a diverse product portfolio.
Key Responsibilities- Develop and execute EU regulatory strategies for new and existing products to ensure compliance and business objectives are met.
- Oversee all regulatory submissions, variations, renewals, extensions, and lifecycle management activities.
- Ensure compliance with EU regulatory requirements for medicinal products, and combination products.
- Lead, coach, and develop a team of Regulatory Affairs, ensuring high-quality and timely delivery of regulatory activities.
- Monitor regulatory developments, assess business impact, and provide regulatory intelligence and recommendations.
- Partner with Business Development, R&D, Quality, and external stakeholders to evaluate regulatory feasibility and support strategic projects.
- Identify and mitigate regulatory risks, providing guidance on timelines, requirements, and market entry pathways.
- Develop and deliver regulatory training programs to strengthen compliance awareness and regulatory knowledge across the organization.
- Degree in Pharmacy, Life Sciences, Natural Sciences, or a related field.
- Minimum 10 years of Regulatory Affairs experience within the pharmaceutical industry.
- Strong knowledge of EU regulatory requirements, lifecycle management, and regulatory submission processes.
- Proven leadership experience managing and developing regulatory teams.
- Excellent strategic thinking, stakeholder management, communication, and cross-functional.
Core Responsibilities
Lead and oversee all Regulatory Affairs activities across the European Union to ensure compliance and strategic support for product portfolios. Manage the regulatory team and drive strategies for submissions, renewals, and market entry pathways.
Requirements
Requires a degree in Pharmacy, Life Sciences, or a related field with at least 10 years of pharmaceutical regulatory experience. Must have proven leadership skills and deep knowledge of EU regulatory requirements and submission processes.
About Eva Pharma
Industry: Pharmaceutical Manufacturing
Company size: 1,001-5,000 employees
EVA Pharma is dedicated to improving access to affordable, high-quality medicines around the world, focusing on three core pillars: innovation, development and sustainable access. The company leverages cutting-edge technology at two research centers bringing first-of-its-kind capabilities to the Middle East and Africa including mRNA research and development from AI prediction to biological products. With a 5,000-strong team of professionals, EVA Pharma produces more than one million healthcare products a day at four state-of-the-art manufacturing facilities, which are internationally recognized for innovation, and have been approved by multiple regulatory agencies. Guided by a relentless drive to ensure sustainable access to pressing yet unmet disease areas, the company’s product portfolio focuses on twelve therapeutic areas: Anti-infectives, metabolic health, bone, neuroscience, oncology, respiratory, gynecology, urology and andrology, pediatrics, ophthalmology, gastrointestinal tract, family medicine to meet both local and international demand. EVA Pharma is one of the fastest-growing healthcare companies in the Middle East and Africa, with an extensive pan-African presence, while operating in more than 60 countries worldwide.