المدير الأول، الشؤون التنظيمية للأسواق الناشئة في منطقة أوروبا والشرق الأوسط وأفريقيا

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.

Desired Candidate Profile

• 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.