Sr Dir, EMEA Emerging Markets Reg Affairs

Role overview

Responsibilities

• Lead and develop regional, cluster, and country regulatory teams, with clear accountability, performance expectations, and succession plans.
• Set strategy across development, evidence generation, filings, registration, launch, labeling, portfolio optimization, and lifecycle management.
• Enable timely submissions, approvals, launches, and patient access, using appropriate accelerated pathways.
• Advise senior cross-functional leaders while maintaining regulatory independence and compliance.
• Represent Regulatory Affairs in portfolio, launch, supply, licensing, due-diligence, and business-development decisions.
• Forecast demand, deploy resources, and manage approximately USD 10 million in budgets.
• Maintain submission, registration, labeling, renewal, translation, artwork, and other lifecycle compliance.
• Ensure controls, training, inspection readiness, remediation, performance data, and suitable systems.
• Build health-authority relationships; assess policy trends and shape the external regulatory environment.

Required qualifications

• Advanced degree in science, health, pharmacy, medicine, or another relevant field.
• At least 15 years of pharmaceutical industry experience, including substantial Regulatory Affairs experience.
• Successful leadership of regulatory strategy across countries, therapeutic areas, and product lifecycle stages.
• Emerging Markets expertise and understanding of local laws, health-authority expectations, business practices, and access considerations.
• Senior-level health-authority interaction and negotiation experience.
• Deep knowledge of development, registration, submissions, labeling, data management, lifecycle management, and compliance.
• Experience optimizing processes through automation and AI with appropriate governance and compliance.
• Experience leading multicultural, dispersed teams, including talent development, performance, succession, and organizational design.
• Strong financial, resource, project, risk, and change-management capabilities; excellent English communication and executive presence.
• 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 or regulatory agency.
• Knowledge of reliance, work-sharing, and other accelerated regulatory pathways.

Travel and work context

• Requires approximately 15–25% travel within EMEA and internationally.
• Operates independently across a geographically dispersed, matrixed organization.