Regulatory Affairs Director - Central Regulatory Affairs (CRA), Europe
Core
Lead European regulatory strategy for a diverse portfolio of medicinal products, ensuring compliant and timely delivery to patients across Europe.
Role type
Senior IC Regulatory Affairs Director (Strategy & People Leadership)
Builds
Regulatory strategies, submission dossiers, and compliant product lifecycles for generics, established brands, and innovative medicines.
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
European regulatory strategy, team leadership, stakeholder engagement, health authority liaison, risk management, cross-functional partnership
Preferred skills
Masters in Regulatory Affairs
Technologies
N/A
Responsibilities
Lead a high-performing team of Regulatory professionals; Accountable for all Regulatory activities impacting European markets; Ensure delivery of regulatory objectives through effective planning; Serve as a primary liaison with regulatory authorities (e.g., EMA); Anticipate changes in regulations and develop risk mitigation strategies; Represent the company at industry associations and conferences.
Seniority
Senior, hands-on IC with people management