EMEA Emerging Markets Regulatory Strategy Director

Johnson & Johnson Co.; Beerse; Vor Ort; EUR 180.000 - 240.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs to lead regulatory strategy and execution across Africa, the Middle East, Türkiye, and the CIS. The role oversees a large team and a substantial regulatory budget, guiding portfolio priorities and lifecycle management while ensuring compliance and timely market access.

The position reports to the VP, with dotted-line to the Executive VP, Emerging Markets, and requires proximity to key stakeholders

Aufgaben

• Leading and developing a high-performing, inclusive regulatory organization across regional, cluster, and country teams, with clear accountability, decision rights, performance expectations, and succession plans.
• Setting and executing regulatory strategy across development, evidence generation, filing sequence, registration, launch, labeling, portfolio optimization, and lifecycle management for all therapeutic areas in scope.
• Enabling timely submissions, approvals, launches, and patient access through high-quality multinational and country strategies, including appropriate use of reliance, work-sharing, abridged, and other accelerated pathways in support of and aligned to the EM commercial strategy.
• Making informed trade-off decisions across portfolio, market, resource, compliance, and business priorities, and escalating material risks with clear options and recommendations.
• Advising senior commercial, research and development, medical, market access, safety, quality, supply chain, and Global Health Equity leaders while maintaining regulatory independence and compliance.
• Representing Regulatory Affairs in portfolio, launch, evidence, supply-network, licensing, due-diligence, and business-development decisions, ensuring regional and country requirements are considered early.

Jobbeschreibung

Johnson & Johnson is seeking a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs to lead regulatory strategy and execution across Africa, the Middle East, Türkiye, and the CIS. The role oversees a large team and a substantial regulatory budget, guiding portfolio priorities and lifecycle management while ensuring compliance and timely market access.

The position reports to the VP, with dotted-line to the Executive VP, Emerging Markets, and requires proximity to key stakeholders