Director, RA Global Regulatory Strategy

About This Role

This Director-level role involves developing and implementing global regulatory strategies for products within a therapeutic area, leading cross-functional teams to secure and maintain market approvals and ensuring compliance with global regulations.

Responsibilities

• Develop and implement global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area
• Lead the Global Regulatory Product Team (GRPT)
• Ensures strategic messaging and content of global regulatory dossiers
• Serve as the primary regulatory interface with AST and supporting teams
• Proactively anticipate and mitigate regulatory risks
• Manage compounds through all phases of development, including post approval and throughout the life cycle of the product
• Develop and implement acceleration strategies
• Make decisions regarding work processes or operational plans and schedules to achieve program objectives
• Lead cross-functional stakeholders and regulatory professionals to ensure appropriate strategic messaging in global regulatory dossiers
• Ensure alignment of global regulatory strategies with Sr. Management

Requirements

• 7+ years regulatory experience (pharmaceutical regulatory work or other R&D role/specialized training)
• Drug development experience in US&C region
• 5+ years in a strategic leadership role with strong project management skills
• Experience working in a complex and matrix environment with multiple stakeholders
• Experience influencing cross-functional teams
• Experience interfacing with major government regulatory bodies
• Strong communication and proactive negotiation skills
• Experience developing and implementing successful global regulatory strategies

Qualifications

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject
• 7+ years regulatory experience, with 5+ years in a strategic leadership role, including drug development experience in US&C region and managing projects

Nice to Have

• Relevant advanced degree
• Certification
• 10+ years experience in pharmaceutical regulatory activities
• Experience as lead regulatory product strategist in two or more major regions (e.g., EU or Japan)
• Strong global drug development foundation with business acumen

Benefits