Sr Director, Regulatory Affairs Strategy

Responsibilities

• Lead and influence stakeholders to drive regulatory success across functions
• Develop and execute global regulatory strategies for complex assets
• Provide leadership in major regulatory submissions and lifecycle management
• Represent regulatory affairs in governance and health authority interactions
• Identify regulatory hurdles and innovative pathways for development
• Gather regulatory intelligence and manage influence at the portfolio level
• Lead regulatory strategy for business development and due diligence initiatives

Qualifications

• 15+ years of regulatory affairs experience in the US and international environments
• Higher degree (MS, Ph.D., or PharmD) in a scientific discipline
• In-depth knowledge of US FDA and global pharmaceutical regulations
• Strong leadership and interpersonal skills, both verbal and written
• Critical thinking and project management skills proven in drug development teams
• Ability to work autonomously or in a team environment

Benefits

• Comprehensive health, dental, and vision insurance
• Generous paid time off including vacation, holidays, and personal days
• Hybrid work environment with remote work options
• Onsite amenities including gym, pool, and catering
• Professional development opportunities