Global Regulatory Affairs Director
Core
Provide strategic and operational regulatory leadership for the development, commercialization, and life cycle management of assigned pharmaceutical products.
Role type
Senior IC Global Regulatory Affairs Director
Builds
Product registrations, license maintenance, and regulatory strategies for new and existing drugs
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Required skills
Regulatory strategy, lobbying and influencing authorities, risk assessment, compliance management, cross-functional collaboration, team leadership, project management
Preferred skills
Advanced degree (MS, PharmD, PhD), experience at a health authority, broad background in multiple regulatory groups
Technologies
Regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance
Responsibilities
Provide strategic regulatory advice for product development; represent the company on external trade association committees; ensure risk assessments and mitigation plans in regulatory strategy documents; contribute to global development programs with expert advice on market legislation; ensure effective collaboration across global, regional, and local regulatory interfaces; participate in skill development and coaching of regulatory staff; ensure market compliance with product licenses and close compliance gaps.
Seniority
Senior, hands-on IC with leadership responsibilities