Senior Director, EMEA Emerging Markets Regulatory Affairs

About the role

Johnson & Johnson's Innovative Medicine division is looking for a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs. The role covers continental Africa, the Middle East, Turkey and Russia and the Commonwealth of Independent States, plus regulatory leadership for remaining Global Health Equity licenses and markets. It reports to the Vice President, Head of Regional Regulatory Affairs, with a dotted line to the Executive Vice President, Emerging Markets, and leads about 80 colleagues and a budget of around USD 10 million. The position may be based in any of the listed countries, with emerging markets locations preferred.

Key responsibilities

• Lead and develop an inclusive regulatory organization across regional, cluster and country teams, with accountability, decision rights, performance expectations 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 in scope.
• Enable timely submissions, approvals, launches and patient access using multinational and country strategies, including reliance, work-sharing, abridged and other accelerated pathways.
• Manage regulatory budgets, forecast demand for major filings and lifecycle activities, and maintain compliance across submissions, registrations, labeling updates, variations, renewals and translations.
• Build senior relationships with health authorities, advise commercial, R&D, medical, market access, safety, quality, supply chain and Global Health Equity leaders, and represent Regulatory Affairs in portfolio, launch, evidence, licensing and business-development decisions.
• Assess emerging legislation and guidance, shape the external regulatory environment through health authorities, trade associations and industry coalitions, and lead negotiations in partnership with global, regional and country teams.

Required profile

• Advanced degree in science, health, pharmacy, medicine or another relevant field.
• At least 15 years of pharmaceutical industry experience, including substantial regulatory affairs experience.
• Demonstrated success leading regulatory strategy across countries, therapeutic areas and product lifecycle stages.
• Relevant emerging markets experience and deep knowledge of drug development, registration, submissions, labeling, data management, lifecycle management and compliance.
• Experience leading multicultural, geographically dispersed teams through direct and matrix relationships, including talent development, performance management and succession.
• Significant experience negotiating with health authorities and representing a company at senior level.
• Strong financial, resource, project, risk and change-management capabilities.

Required skills

• Preferred: broader regional and global regulatory affairs experience, experience in a local operating company or regulatory agency, and knowledge of reliance, work-sharing and other accelerated pathways.
• Experience leading process optimization, including automation and AI, while maintaining governance and compliance.
• Excellent English, with executive presence, stakeholder management, negotiation and conflict resolution.