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
Regulatory strategies, submission packages, and compliance frameworks for new and existing drug registrations
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic regulatory leadership, lobbying and influencing regulatory authorities, risk assessment and mitigation, global regulatory strategy, compliance management, stakeholder management, project 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 submission systems, compliance tracking tools
Responsibilities
Influence regulatory agencies and trade associations on product and legislative development issues, provide strategic regulatory advice for regional therapy areas, represent the company on external Trade Association committees, ensure risk assessments and mitigation plans in regulatory strategy documents, contribute expert advice on market legislation for product registrations, enable effective global/regional/local regulatory collaboration, participate in skill-development and coaching of regulatory staff, ensure market compliance with product licenses
Seniority
Director, strategic leadership & team management
