About the Role
Johnson & Johnson seeks a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs to lead regulatory strategy and execution across continental Africa, the Middle East, Türkiye, Russia, and the Commonwealth of Independent States. This leadership position reports to the Vice President, Head of Regional Regulatory Affairs, with a dotted-line relationship to the Executive Vice President, Emerging Markets.
Key Responsibilities
- Lead and develop a high-performing, inclusive regulatory organization across regional, cluster, and country teams with clear accountability and succession plans
- Set and execute regulatory strategy across development, evidence generation, filing sequence, registration, launch, labeling, and lifecycle management for all therapeutic areas
- Enable timely submissions, approvals, and launches through multinational and country strategies, including reliance, work-sharing, and accelerated pathways
- Make informed trade-off decisions across portfolio, market, resource, compliance, and business priorities, escalating material risks with clear recommendations
- Advise senior commercial, R&D, medical, market access, safety, quality, and supply chain leaders while maintaining regulatory independence
- Manage approximately USD 10 million in regulatory budgets with disciplined financial oversight and long-range planning
Required Qualifications
- Advanced degree in science, health, pharmacy, medicine, or relevant field
- At least 15 years of pharmaceutical industry experience with substantial Regulatory Affairs background
- Demonstrated success leading regulatory strategy across multiple countries, therapeutic areas, and product lifecycle stages
- Relevant Emerging Markets experience with strong understanding of regional laws and health-authority expectations
- Significant experience interacting and negotiating with health authorities at senior level
- Deep knowledge of drug development, registration, submissions, labeling, and regulatory compliance
- Experience leading process optimization, including automation and AI adoption for regulatory efficiency
- Proven ability to lead multicultural, geographically dispersed teams through direct and matrix relationships
- Strong financial, resource, project, and risk-management capabilities
- Excellent English communication, executive presence, and stakeholder management skills
Preferred Qualifications
- Broader regional and global Regulatory Affairs experience
- Experience in a local operating company or regulatory agency
- Knowledge of reliance, work-sharing, and accelerated regulatory pathways
Additional Information
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. The position requires 15-25% travel within the EMEA region and internationally. Candidates must be currently based in one of the listed EMEA locations (Belgium, UAE, Saudi Arabia, Turkey, Egypt, Lebanon, Morocco, or South Africa).
Mise en forme par Postule ·
Signaler un problème