EMEA Emerging Markets Regulatory Affairs Leader

Biopharma Careers; Riyadh; Vor Ort; SAR 1.125.000 - 2.250.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs. The role leads a large, diverse regional team across Africa, the Middle East, Türkiye, and CIS, aligning regulatory strategy with portfolio priorities, patient access, and launches.

It involves significant interaction with health authorities, senior leadership, and cross-functional teams. The position manages roughly USD 10 million in regulatory budgets, guiding lifecycle activities, submissions,

Qualifikationen

• 15+ years in pharmaceutical Regulatory Affairs.
• Experience leading regulatory strategy across multiple countries and product lifecycles.
• Strong understanding of EM regional laws, health-authority expectations, and access considerations.
• Proven ability to lead multicultural, geographically dispersed teams and manage budgets.

Aufgaben

• Lead regulatory strategy and execution for EM across Africa, Middle East, Türkiye, and CIS.
• Oversee filings, submissions, labeling, lifecycle management, and launches.
• Manage approximately USD 10 million in regulatory budgets with governance.
• Advise senior leaders across Commercial, R&D, Safety, and Quality on regulatory risks and opportunities.
• Engage health authorities and stakeholders to influence policy and approvals.
• Forecast regulatory demand and allocate resources for major filings and lifecycle activities.

Kenntnisse

Regulatory leadership

Global regulatory strategy

Stakeholder management

English communication

Budget management

Cross-cultural leadership

Ausbildung

Advanced degree

Jobbeschreibung

Johnson & Johnson is seeking a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs. The role leads a large, diverse regional team across Africa, the Middle East, Türkiye, and CIS, aligning regulatory strategy with portfolio priorities, patient access, and launches.

It involves significant interaction with health authorities, senior leadership, and cross-functional teams. The position manages roughly USD 10 million in regulatory budgets, guiding lifecycle activities, submissions,