Sr Dir EMEA Emerging Markets Reg Affairs

About the Role

Johnson & Johnson is seeking a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs. This full-time position is based in Riyadh and requires over 10 years of experience. The role focuses on leading regulatory strategy and execution across continental Africa, the Middle East, Türkiye, Russia, and the Commonwealth of Independent States, while also providing regulatory leadership for remaining Global Health Equity licenses and markets.

Role Purpose and Scope

Reporting to the Vice President, Head of Regional Regulatory Affairs, with a dotted-line to the Executive Vice President, Emerging Markets, this leader aligns regional and country strategies with portfolio priorities, patient access, product launches, lifecycle management, and sustained compliance. The role involves leading approximately 80 colleagues through direct and matrix relationships and is accountable for approximately USD 10 million in regional, local, and Global Health Equity regulatory budgets. This position operates with a high degree of independence across a geographically dispersed, matrixed organization.

Key Responsibilities

• Lead and develop a high-performing, inclusive regulatory organization across regional, cluster, and country teams.
• 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 through high-quality multinational and country strategies.
• 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.
• 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 of 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 Requirements

• Education: An advanced degree in science, health, pharmacy, medicine, or another relevant field is required.
• Experience: At least 15 years of relevant pharmaceutical industry experience, including substantial experience in Regulatory Affairs.
• Regulatory Leadership: Demonstrated success leading regulatory strategy and execution across multiple countries, therapeutic areas, and product lifecycle stages.
• Emerging Markets Expertise: Relevant Emerging Markets experience with a strong understanding of regional and country laws, health-authority expectations, business practices, and access considerations.
• Health Authority Interaction: Significant experience interacting and negotiating with health authorities and representing a company at a senior level.
• Regulatory Knowledge: Deep knowledge of drug development, registration, submissions, labeling, data management, lifecycle management, and regulatory compliance.
• Process Optimization: Demonstrated experience leading process optimization, including the adoption of automation and artificial intelligence (AI), to deliver measurable improvements in regulatory efficiency, quality, and execution while maintaining appropriate governance and compliance.
• Team Leadership: Experience leading multicultural, geographically dispersed teams through direct and matrix relationships, including talent development, performance management, succession, and organizational design.
• Management Capabilities: Strong financial, resource, project, risk, and change-management capabilities.
• Communication Skills: Excellent English communication, executive presence, stakeholder management, influencing, negotiation, and conflict-resolution skills.
• Decision Making: Ability to simplify complex issues, establish clear governance, make principled decisions, and deliver outcomes in ambiguous, high-risk situations.
• Ethical Commitment: 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.

Work Environment and Travel

The position is based in Riyadh and requires approximately 15-25% travel within the EMEA region and internationally. The role operates with a high degree of independence across a geographically dispersed, matrixed organization.