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 Director, Global Regulatory Affairs
Builds
Product registrations, license maintenance, and regulatory strategies for new and existing drugs.
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Required skills
Strategic regulatory leadership, lobbying and influencing regulatory authorities, project management, risk assessment, compliance management, cross-functional collaboration, team coaching.
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 licence maintenance.
Responsibilities
Influence regulatory agencies and trade associations on product and legislative development issues; 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 programmes with expert advice on market legislation; collaborate across global, regional, and local Regulatory Affairs interfaces; participate in skill-development and coaching of regulatory staff; ensure market compliance with product licenses and close compliance gaps.
Seniority
Director, strategic leadership with hands-on operational oversight.