Senior Director, Head of EMEA Emerging Markets Regulatory Affairs

About the Role

Johnson & Johnson seeks a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs to lead regulatory strategy and execution across continental Africa, the Middle East, Türkiye, and Russia and the Commonwealth of Independent States. This senior leadership position reports to the Vice President, Head of Regional Regulatory Affairs, with a dotted-line relationship to the Executive Vice President, Emerging Markets.

You will lead approximately 80 colleagues through direct and matrix relationships and manage approximately USD 10 million in regional, local, and Global Health Equity regulatory budgets.

Main Responsibilities

• Lead and develop a high-performing, inclusive regulatory organization across regional, cluster, and country teams with clear accountability, decision rights, and succession plans
• Set and execute regulatory strategy across development, evidence generation, filing sequence, registration, launch, labeling, portfolio optimization, and lifecycle management for all therapeutic areas
• Enable timely submissions, approvals, launches, and patient access through multinational and country strategies, including reliance, work-sharing, and accelerated pathways
• Make informed trade-off decisions across portfolio, market, resource, compliance, and business priorities, escalating material risks with clear options and recommendations
• Advise senior commercial, R&D, medical, market access, safety, quality, supply chain, and Global Health Equity leaders while maintaining regulatory independence and compliance
• Represent Regulatory Affairs in portfolio, launch, evidence, supply-network, licensing, and business-development decisions
• Forecast demand and deploy resources for major filings and lifecycle activities in partnership with local managing directors and cluster leaders
• Manage approximately USD 10 million in regulatory budgets with long-range planning and disciplined financial oversight
• Maintain compliance across submissions, regulatory commitments, registrations, labeling updates, variations, renewals, and lifecycle obligations
• Build senior relationships with health authorities and guide key interactions and negotiations
• Assess emerging legislation, guidance, and policy trends, translating them into implications for development, registration, and access strategies
• Shape the external regulatory environment through health authorities, trade associations, and industry coalitions

Required Qualifications

• Advanced degree in science, health, pharmacy, medicine, or another relevant field
• At least 15 years of relevant pharmaceutical industry experience, including substantial experience in Regulatory Affairs
• Demonstrated success leading regulatory strategy and execution across multiple countries, therapeutic areas, and product lifecycle stages
• Relevant Emerging Markets experience with strong understanding of regional and country laws, health-authority expectations, and access considerations
• Significant experience interacting and negotiating with health authorities at senior level
• Deep knowledge of drug development, registration, submissions, labeling, data management, lifecycle management, and regulatory compliance
• Demonstrated experience leading process optimization, including adoption of automation and artificial intelligence (AI)
• Experience leading multicultural, geographically dispersed teams through direct and matrix relationships
• Strong financial, resource, project, risk, and change-management capabilities
• Excellent English communication, executive presence, stakeholder management, influencing, and negotiation skills
• Ability to simplify complex issues, establish clear governance, and deliver outcomes in ambiguous, high-risk situations
• Demonstrated commitment to patients, quality, ethics, compliance, inclusion, and psychologically safe collaboration

Preferred Qualifications

• Broader regional and global Regulatory Affairs experience
• Experience in a local operating company and/or regulatory agency
• Knowledge of reliance, work-sharing, and other accelerated regulatory pathways

Additional Information

The role requires approximately 15–25% travel within the EMEA region and internationally. The position operates with a high degree of independence across a geographically dispersed, matrixed organization. Candidates must be currently based in one of the listed locations: Belgium, UAE, Saudi Arabia, Turkey, Egypt, Lebanon, Morocco, or South Africa.