Senior Regulatory Affairs Specialist - Sub-Saharan Africa

About the Role

Our client, a dynamic multinational pharmaceutical company, is seeking a highly experienced Senior Regulatory Affairs Specialist with a focus on the Sub-Saharan African markets. This role, based in East London, Eastern Cape, is crucial for managing regulatory submissions, ensuring compliance with local regulations, and supporting the company's strategic objectives across the region. The ideal candidate will possess in-depth knowledge of the regulatory landscape in key African countries and a proven track record of successfully navigating complex submission processes. This is an exceptional opportunity to contribute to bringing vital medicines to patients across diverse markets within a challenging and rewarding environment. You will work closely with regional teams, health authorities, and internal stakeholders to facilitate product registrations and lifecycle management. We are seeking a proactive, detail-oriented professional with strong analytical and communication skills. The hybrid work model allows for a balance of office-based work and remote flexibility, supporting efficient operations across the region. This role offers significant career growth potential within a globally recognized pharmaceutical organization.

Key Responsibilities

• Develop and execute regulatory strategies for product registrations and lifecycle management in Sub-Saharan African countries.
• Prepare, submit, and maintain regulatory dossiers in accordance with country-specific requirements (e.g., ART, SAHPRA, NAFDAC).
• Serve as the primary point of contact for regulatory health authorities in the assigned region.
• Liaise with internal departments (e.g., Marketing, Medical Affairs, Clinical Operations) and external partners to ensure regulatory compliance.
• Monitor changes in the regulatory environment and assess their impact on the company's portfolio.
• Provide regulatory guidance and support to cross-functional teams.
• Review and approve promotional materials for compliance with local regulations.
• Manage post-approval changes and variations.
• Contribute to the development of regulatory intelligence and training materials.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. A Master's degree or relevant professional certification is preferred.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs, with a significant focus on Sub-Saharan Africa.
• In-depth knowledge of regulatory requirements and submission processes in key African markets (e.g., South Africa, Nigeria, Kenya, Ghana).
• Proven experience in preparing and submitting marketing authorization applications (MAAs).
• Strong understanding of pharmaceutical product development, manufacturing, and quality assurance.
• Excellent communication, negotiation, and interpersonal skills.
• Ability to work independently, manage multiple projects, and meet tight deadlines.
• Proficiency in regulatory information management (RIM) systems is a plus.
• Fluency in English is required; knowledge of other relevant languages is advantageous.

Benefits

• Our client offers a highly competitive salary, commensurate with experience, and a comprehensive benefits package.
• Excellent medical, dental, and vision insurance.
• A significant annual bonus opportunity is provided.
• Employees benefit from a generous paid time off policy.
• Opportunities for professional development and global mobility are readily available.
• Our client is committed to fostering a supportive work environment and promoting a healthy work-life balance for all employees in East London, Eastern Cape.
• Join a team dedicated to ensuring patient access to essential medicines across Africa.