Head of Regulatory Affairs, EMEA Emerging Markets

Kizuna Edge Talent Hub; Belgium; Remote; EUR 150,000 - 250,000; Full time

Job summary

KETH Africa seeks a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs to lead regulatory strategy across Africa, the Middle East, Türkiye, and the CIS. The role supervises ~80 colleagues, manages ~USD 10 million in budgets, and ensures compliance while partnering with global and regional teams.

Based in one of the EM locations, the role requires strong leadership, negotiation with health authorities, and a deep understanding of drug development, submissions, and lifecycle

Qualifications

• Advanced degree in science, health, pharmacy, medicine, or another relevant field.
• At least 15 years of relevant pharmaceutical industry experience with Regulatory Affairs.
• Experience leading regulatory strategy across multiple countries and product lifecycles.
• Emerging Markets experience with regional and country laws, health-authority expectations, and access considerations.

Responsibilities

• Lead regulatory strategy and execution across Africa, the Middle East, Türkiye, and Russia, and oversee Global Health Equity licenses.
• Manage a ~USD 10 million regulatory budget with long-range planning and governance.
• Guide interactions with health authorities and senior leaders while ensuring regulatory independence and compliance.
• Forecast demand and allocate resources for major filings and lifecycle activities across regional and country teams.
• Build and develop a high-performing regulatory organization with clear accountability and succession plans.

Skills

Regulatory strategy

Global health equity

Stakeholder management

Budget management

Cross-functional leadership

Health authority negotiation

Education

Advanced degree in science/health/pharmacy/medicine

Job description

KETH Africa seeks a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs to lead regulatory strategy across Africa, the Middle East, Türkiye, and the CIS. The role supervises ~80 colleagues, manages ~USD 10 million in budgets, and ensures compliance while partnering with global and regional teams.

Based in one of the EM locations, the role requires strong leadership, negotiation with health authorities, and a deep understanding of drug development, submissions, and lifecycle