Senior Regulatory Strategy Manager

Senior Regulatory Strategy Manager role at a biopharmaceutical company focused on neurological and psychiatric disorders. Leads regulatory strategy, oversees submission preparation, manages cross-functional teams, and ensures compliance with FDA and international regulations.

Responsibilities

• Lead development, review, and filing of INDs, CTAs, briefing documents, DSURs, and annual reports for development and approved applications
• Develop global regulatory strategies collaboratively and maintain awareness of regulatory intelligence across product classes
• Manage project timelines for regulatory submissions and conduct critical review of clinical study documentation
• Develop and implement standard operating procedures and department working practices for regulatory compliance
• Interface with US and international regulatory authorities; mentor less experienced colleagues on regulatory expertise and best practices

Requirements

• BS/BA in Life/Health Sciences plus 8+ years industry experience, including 6+ years regulatory affairs in drug development at research-based pharma with 2+ years in lead capacity
• Master's degree in Life/Health Sciences preferred with 6+ years related experience
• Expert-level knowledge of FDA regulations and ICH guidelines for submissions
• Demonstrated understanding of drug development laws, regulations, and ex-US regulatory knowledge preferred
• Strong project management, leadership, and mentoring capabilities with ability to lead multiple teams
• Excellent analytical, communication, and problem-solving skills with ability to manage multiple deadlines independently