EMEA Emerging Markets Regulatory Director

Johnson & Johnson Co.

Beerse

Sur place

EUR 153 000 - 264 000

Plein temps

Il y a 7 jours
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Résumé du poste

Johnson & Johnson seeks a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs to lead regulatory strategy and execution across Africa, the Middle East, Türkiye, and Russia. This role coordinates with Global Health Equity and regional partners, overseeing a ~10M USD budget and ~80 colleagues, with proximity to key stakeholders in listed EM locations.

The role reports to VP Regional Regulatory Affairs, aligning strategies with portfolio priorities, patient access, and launches, while

Qualifications

  • Advanced degree in science, health, pharmacy, medicine, or other relevant field.
  • 15+ years of pharmaceutical industry experience, including Regulatory Affairs.
  • Experience leading regulatory strategy across multiple countries and product lifecycles.
  • Emerging Markets regulatory experience with regional and country laws and access considerations.
  • Significant interaction with health authorities at senior levels.
  • Deep knowledge of drug development, submissions, labeling, and lifecycle management.
  • Experience leading multicultural, matrixed teams and budget oversight.

Responsabilités

  • Lead and develop a high-performing regulatory organization across regional, cluster, and country teams.
  • Set and execute regulatory strategy for development, evidence generation, filing, registration, and lifecycle management.
  • Enable timely submissions, approvals, launches, and patient access with multinational strategies.
  • Make informed trade-off decisions across portfolio, markets, and budgets; escalate material risks.
  • Advise senior leaders across commercial, R&D, safety, and quality while ensuring compliance.
  • Represent Regulatory Affairs in portfolio, launch, and licensing decisions with regional and country input.
  • Forecast demand and deploy resources for major filings and lifecycle activities.
  • Manage approximately USD 10 million in regulatory budgets.

Connaissances

Executive presence
Stakeholder management
Negotiation
Change management
Regulatory affairs
Leadership

Formation

Advanced degree in science/health/pharmacy/medicine

Description du poste

Johnson & Johnson seeks a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs to lead regulatory strategy and execution across Africa, the Middle East, Türkiye, and Russia. This role coordinates with Global Health Equity and regional partners, overseeing a ~10M USD budget and ~80 colleagues, with proximity to key stakeholders in listed EM locations.

The role reports to VP Regional Regulatory Affairs, aligning strategies with portfolio priorities, patient access, and launches, while

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