Sr Dir EMEA Emerging Markets Reg Affairs

About Johnson & Johnson

Johnson & Johnson is dedicated to healthcare innovation, aiming to prevent, treat, and cure complex diseases, develop smarter and less invasive treatments, and provide personalized solutions. The company operates across Innovative Medicine and MedTech sectors. Guided by Our Credo, Johnson & Johnson fosters an inclusive work environment that respects diversity and recognizes the merit of its employees globally.

Role Overview

Johnson & Johnson is seeking a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs. This full-time position is responsible for leading regulatory strategy and execution across continental Africa, the Middle East, Türkiye, Russia, and the Commonwealth of Independent States. The role also provides regulatory leadership for Global Health Equity licenses and markets. This position may be based in Riyadh, Saudi Arabia, or other listed countries, with a preference for Emerging Markets locations to ensure proximity to key stakeholders. Candidates must currently reside in one of the listed locations.

Key Responsibilities

• Lead and develop a high-performing, inclusive regulatory organization across regional, cluster, and country teams, establishing clear 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 within scope.
• Enable timely submissions, approvals, launches, and patient access through high-quality multinational and country strategies, utilizing reliance, work-sharing, abridged, and other accelerated pathways aligned with the EM commercial strategy.
• Make informed trade-off decisions across portfolio, market, resource, compliance, and business priorities, escalating material risks with clear options and recommendations.
• Advise senior commercial, research and development, 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, due-diligence, and business-development decisions, ensuring regional and country requirements are considered early.
• Forecast demand and deploy resources for major filings and lifecycle activities, in partnership with local managing directors, cluster leaders, and country regulatory heads.
• Manage approximately USD 10 million in regulatory budgets, including long-range planning, funding decisions, and disciplined financial oversight.
• Maintain compliance across submissions, regulatory commitments, registrations, labeling updates, variations, renewals, translations, artwork, and other lifecycle obligations.
• Ensure effective controls, training, inspection readiness, remediation, performance data, and fit-for-purpose systems across the region.
• Build senior relationships with health authorities and guide key interactions and negotiations in partnership with global, regional, and country teams.
• Assess emerging legislation, guidance, review practices, and policy trends, translating them into clear implications for development, registration, lifecycle, supply, and access strategies.
• Shape the external regulatory environment through health authorities, trade associations, industry coalitions, and other relevant stakeholders.

Qualifications and Experience

• A minimum of 10 years of experience in regulatory affairs or a related field.
• Demonstrated leadership experience, managing approximately 80 colleagues through direct and matrix relationships.
• Ability to align regional and country strategies with portfolio priorities, patient access, product launches, lifecycle management, and sustained compliance.
• Experience in managing significant budgets and deploying resources effectively.

Work Environment and Reporting

This role reports to the Vice President, Head of Regional Regulatory Affairs, with a dotted-line relationship to the Executive Vice President, Emerging Markets. The position operates with a high degree of independence within a geographically dispersed, matrixed organization. Approximately 15-25% travel within the EMEA region and internationally is required. The salary range for this position in Belgium is 152,900 - 264,385 EUR.