Director, RA Global Regulatory Strategy

📋 Description

• Develop and implement global regulatory strategies to secure and maintain market approval for
• Lead the Global Regulatory Product Team (GRPT) and serve as the primary regulatory interface with
• Lead Labeling Regulatory Strategy Team (LRST) and manage products through all phases of development
• Proactively anticipate and mitigate regulatory risks, ensuring compliance with global regulatory
• Develop and implement acceleration strategies and manage regulatory documentation.
• Lead cross-functional stakeholders to ensure strategic messaging in regulatory dossiers.

🎯 Requirements

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• 7+ years regulatory experience, with some portion in pharmaceutical regulatory work.
• Requires drug development experience in US & C region.
• Proven 5+ years in a strategic leadership role with strong project management skills.
• Experience in a complex matrix environment with multiple stakeholders.
• Experience interfacing with major government regulatory agencies.

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Long-term incentive programs