Global Regulatory Affairs Director

AstraZeneca seeks a Global Regulatory Affairs Director in Gaithersburg to provide strategic regulatory leadership for assigned products across development, commercialization, and lifecycle management. The role includes managing regulatory teams, influencing regulatory agencies, and ensuring compliance across global markets.

Responsibilities

• Provide strategic regulatory advice and leadership for product development and commercialization initiatives
• Advocate to regulatory agencies and trade associations on product and legislative matters
• Manage regulatory skill groups including CMC and project management, overseeing staffing and performance
• Ensure risk assessments and mitigation plans are integrated into regulatory strategy documents
• Maintain compliance with product licenses across markets and coordinate global regulatory submissions

Requirements

• Bachelor's degree in life science or related discipline; advanced degree preferred
• 6+ years regulatory drug development, manufacturing, commercialization, or equivalent experience
• Proven leadership and project management experience
• Broad background working across multiple regulatory affairs groups or health authority experience
• Knowledge of regulatory procedures and legislation for drug development and product registration

Compensation: $186,232-$279,349 base annual pay