Sr Dir, EMEA Emerging Markets Reg Affairs

Role purpose and scope

Leadership and regulatory responsibilities

• Lead and develop inclusive regional, cluster, and country teams, establishing accountability, decision rights, performance expectations, and succession plans.
• Set and execute strategy across development, evidence generation, filing sequence, registration, launch, labeling, portfolio optimization, and lifecycle management.
• Enable timely submissions, approvals, launches, and patient access through multinational and country strategies, including suitable reliance, work-sharing, abridged, and accelerated pathways.
• Make portfolio, market, resource, compliance, and business trade-off decisions and escalate material risks with options and recommendations.
• Advise commercial, R&D, medical, market access, safety, quality, supply chain, and Global Health Equity leaders 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 with local and regional leaders.
• Manage approximately USD 10 million in regulatory budgets, including long-range planning, funding decisions, and financial oversight.
• Maintain compliance across submissions, commitments, registrations, labeling updates, variations, renewals, translations, artwork, and lifecycle obligations.
• Ensure effective controls, training, inspection readiness, remediation, performance data, and fit-for-purpose systems.
• Build senior health-authority relationships and guide interactions and negotiations with global, regional, and country teams.
• Assess regulatory laws, guidance, review practices, and policy trends; shape the external environment through health authorities and industry stakeholders.

Required qualifications

• Advanced degree in science, health, pharmacy, medicine, or another relevant field.
• At least 15 years of relevant pharmaceutical industry experience, including substantial Regulatory Affairs experience.
• Demonstrated success leading regulatory strategy and execution across multiple countries, therapeutic areas, and product lifecycle stages.
• Relevant Emerging Markets experience and 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.
• Experience leading process optimization, including automation and AI adoption, with measurable improvements and appropriate governance and compliance.
• Experience leading multicultural, geographically dispersed teams, 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 governance, make principled decisions, and deliver in ambiguous, high-risk situations.
• Commitment to patients, quality, ethics, compliance, inclusion, and psychologically safe collaboration.

Preferred qualifications

• Broader regional and global Regulatory Affairs experience is preferred.
• Experience in a local operating company and/or regulatory agency is preferred.
• Knowledge of reliance, work-sharing, and other accelerated regulatory pathways is preferred.

Location and travel

• The role may be based in Belgium, UAE, Saudi Arabia, Türkiye, Egypt, Lebanon, Morocco, or South Africa; Emerging Markets locations are preferred.
• Candidates must currently be based in one of the listed locations.
• The role requires approximately 15–25% travel within EMEA and internationally and operates across a geographically dispersed matrix organization.

Compensation

• The anticipated pay range listed for Belgium is EUR 152,900–264,385.