Senior Vice President, Head of Global Regulatory Affairs

📋 Description

• Develop and execute U.S. and global regulatory strategies aligned with business objectives and the
• Provide regulatory direction and expert guidance to development teams and senior leadership
• Lead global regulatory strategy across late-stage development, launch readiness, product
• Oversee regulatory activities related to CMC, preclinical development, clinical development
• Serve as the primary day-to-day liaison with regulatory authorities, leading meeting requests
• Represent Regulatory Affairs on cross-functional development teams and contribute strategically to

🎯 Requirements

• Advanced degree preferred, with extensive experience in pharmaceutical or biotechnology regulatory
• 15+ years of regulatory experience, including at least 10 years in senior leadership roles.
• Demonstrated experience developing and executing regulatory strategies for late-stage, launch, and
• Strong knowledge of the drug development lifecycle and regulatory environments across the United
• Proven experience with post-approval regulatory activities, including labeling strategies, safety
• Experience leading and developing regulatory professionals and managing external regulatory

🎁 Benefits

• Competitive base salary.
• Annual performance bonus opportunity.
• Long-term incentive program.
• Health insurance coverage.
• Dental and vision insurance.
• Term life insurance.