Sr Dir, EMEA Emerging Markets Reg Affairs

Johnson and Johnson; Riyadh; On-site; SAR 1,312,000 - 2,062,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Director, Head of EM Emerging Markets Regulatory Affairs to lead strategy and execution across Africa, the Middle East, Türkiye, and CIS, including Global Health Equity licenses. You will drive regulatory leadership, budget management, and cross-functional governance in a complex, multi-country landscape.

You will guide senior teams and liaise with health authorities to ensure timely registrations, launches, labeling, and lifecycle activities while advancing

Qualifications

• Advanced degree in science, health, pharmacy, medicine, or another relevant field.
• 15+ years in pharmaceutical industry with Regulatory Affairs experience.
• Experience leading regulatory strategy across multiple countries and lifecycle stages.
• Strong understanding of regional laws, health-authority expectations, and access considerations.
• Experience negotiating with health authorities at senior levels.
• Knowledge of drug development, registration, submissions, labeling, and lifecycle management.
• Experience leveraging automation/AI to improve regulatory efficiency while ensuring compliance.
• Leadership of multicultural, dispersed teams including talent development and succession.

Responsibilities

• Lead and develop a high-performing regulatory organization across regional clusters and country teams with clear accountability and succession plans.
• Set and execute regulatory strategy across development, evidence generation, filings, registrations, launches, labeling, and lifecycle management.
• Enable timely submissions, approvals, launches, and patient access with multinational and country strategies.
• Make informed trade-off decisions across portfolio, resources, compliance and business priorities; escalate material risks with options.
• Advise senior leaders across Commercial, R&D, Medical, Market Access, Safety, and Quality while maintaining regulatory independence.
• 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 leaders; manage approximately USD 10 million in budgets.
• Maintain compliance across submissions, regulatory commitments, registrations, labeling updates, variations, renewals, translations, and other lifecycle obligations.

Skills

Regulatory strategy

Global/regional leadership

Stakeholder management

Budget management

Project management

Risk assessment

Change management

Executive communication

Multicultural leadership

Education

Advanced degree in science/health/pharmacy/medicine

Job description

Purpose

The Senior Director Head of EMEA Emerging Markets Regulatory Affairs leads regulatory strategy and execution across continental Africa the Middle East T rkiye and Russia and the Commonwealth of Independent States. The role also provides regulatory leadership for remaining Global Health Equity licenses and markets. Reporting to the Vice President Head of Regional Regulatory Affairs with a dotted-line relationship 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 leads 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 leader sets priorities deploys resources builds organizational capability and succession and represents Regulatory Affairs in senior cross-functional decisions.

You will be responsible for

• Leading and developing a high-performing inclusive regulatory organization across regional cluster and country teams with clear accountability decision rights performance expectations and succession plans.
• Setting and executing regulatory strategy across development evidence generation filing sequence registration launch labeling portfolio optimization and lifecycle management for all therapeutic areas in scope.
• Enabling timely submissions approvals launches and patient access through high-quality multinational and country strategies including appropriate use of reliance work-sharing abridged and other accelerated pathways in support of and aligned to the EM commercial strategy.
• Making informed trade-off decisions across portfolio market resource compliance and business priorities and escalating material risks with clear options and recommendations.
• Advising senior commercial research and development medical market access safety quality supply chain and Global Health Equity leaders while maintaining regulatory independence and compliance.
• Representing Regulatory Affairs in portfolio launch evidence supply-network licensing due-diligence and business-development decisions ensuring regional and country requirements are considered early.
• Forecasting demand and deploying resources for major filings and lifecycle activities in partnership with local managing directors cluster leaders and country regulatory heads.
• Managing approximately USD 10 million in regulatory budgets including long-range planning funding decisions and disciplined financial oversight.
• Maintaining compliance across submissions regulatory commitments registrations labeling updates variations renewals translations artwork and other lifecycle obligations.
• Ensuring effective controls training inspection of readiness remediation performance data and fit-for-purpose systems across the region.
• Building senior relationships with health authorities and guiding key interactions and negotiations in partnership with global regional and country teams.
• Assessing emerging legislation guidance review practices and policy trends translating them into clear implications for development registration lifecycle supply and access strategies.
• Shaping the external regulatory environment through health authorities trade associations industry coalitions and other relevant stakeholders.

Qualifications

• An advanced degree in science, health, pharmacy, medicine, or another relevant field is required.
• 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 a strong understanding of regional and country laws, health-authority expectations, business practices, and access considerations.
• Significant experience interacting and negotiating with health authorities and representing a company at senior level.
• Deep knowledge of drug development, registration, submissions, labeling, data management, lifecycle management, and regulatory compliance.
• 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.
• Experience leading multicultural, geographically dispersed teams through direct and matrix relationships, including talent development, performance management, succession, and organizational design.
• Strong financial, resource, project, risk, and change-management capabilities.
• Excellent English communication, executive presence, stakeholder management, influencing, negotiation, and conflict-resolution skills.
• Ability to simplify complex issues, establish clear governance, make principled decisions, and deliver outcomes in ambiguous, high-risk situations.
• Demonstrated commitment to patients, quality, ethics, compliance, inclusion, and psychologically safe collaboration.

Preferred

• 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.