Director, RA Global Regulatory Strategy

📋 Description

• Lead development and implementation of global regulatory strategies to secure and maintain market
• Serve as the primary regulatory interface with AST and supporting teams; leads the Global
• Proactively anticipate and mitigate regulatory risks; ensure compliance with global regulatory
• Manage compounds through all phases of development, including post-approval and lifecycle.
• Lead preparation of global regulatory product strategies and risk assessment/mitigation plans.
• Influence development of regulations and guidance; analyze legislation and provide analysis to the

🎯 Requirements

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related field
• 7+ years of regulatory experience with drug development experience in US&C region.
• Proven 5+ years in a strategic leadership role with strong project management skills.
• Experience in complex matrix environment with multiple stakeholders and cross-functional teams.
• Strong communication and negotiation skills.
• Experience developing and implementing successful global regulatory strategies.

🎁 Benefits

• Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k).
• Eligibility for long-term incentive programs.