Senior Regulatory Affairs Specialist - Sub-Saharan

Our client, a leading international pharmaceutical company, is seeking a highly experienced Senior Regulatory Affairs Specialist with extensive knowledge of the Sub-Saharan African (SSA) market to join their team in Polokwane. This role is integral to ensuring timely and compliant registration of pharmaceutical products across various SSA countries. You will be responsible for developing regulatory strategies, preparing submission dossiers, and liaising with health authorities to facilitate product approvals.

This is a key position requiring a deep understanding of the complex and evolving regulatory landscapes within the SSA region. The successful candidate will be instrumental in expanding market access for critical medicines. This exciting opportunity is based in Polokwane, Limpopo, a strategic location within the region.

• Develop and implement regulatory strategies for product registration in key Sub-Saharan African markets.
• Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD, eCTD) to health authorities across the SSA region.
• Act as the primary point of contact for health authorities in assigned countries, managing all communication and interactions.
• Monitor and interpret relevant regulatory guidelines and changes within the SSA markets, assessing their impact on the company's portfolio.
• Provide regulatory guidance and support to cross-functional teams, including marketing, R&D, and clinical affairs.
• Ensure ongoing compliance of registered products, managing post-approval variations, renewals, and safety reporting requirements.
• Conduct regulatory intelligence activities to identify emerging trends and opportunities in SSA markets.
• Review promotional and advertising materials for compliance with local regulations.
• Contribute to the development of regulatory policies and procedures.
• Oversee and manage local regulatory consultants and partners as needed.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• A minimum of 6-8 years of progressive experience in pharmaceutical regulatory affairs, with a significant focus on Sub-Saharan African markets.
• Proven track record of successful product registrations in multiple SSA countries.
• In-depth knowledge of the regulatory requirements and submission processes in key SSA markets (e.g., South Africa, Nigeria, Kenya, Ghana).
• Experience with Common Technical Document (CTD) format and electronic submission platforms.
• Strong understanding of pharmaceutical product development, manufacturing, and quality assurance.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Exceptional communication, negotiation, and interpersonal skills.
• Ability to work independently, manage multiple projects, and meet tight deadlines.
• Fluency in English is essential; knowledge of other relevant languages spoken in SSA is a plus.

• Our client offers a competitive salary, performance-based bonuses, and a comprehensive benefits package, including private health insurance, a retirement fund, and life cover.
• Significant opportunities for professional development are provided, including international training programs, conference attendance, and exposure to global regulatory affairs.
• The company culture is dynamic and international, fostering collaboration and innovation, with a commitment to employee growth and work-life balance.
• Generous annual leave and potential relocation assistance are offered.
• This is a challenging and rewarding role contributing to healthcare access in Polokwane and across Africa.