Director, Regulatory Affairs Business Development

📋 Description

• Responsible for preparing oral and written regulatory scientific assessments for potential
• Responsible for preparing GRS evaluations and recommendations for venture investment opportunities
• Responsible for leading GRS activities supporting the out-license/divestiture of AbbVie development
• Responsible for developing the regulatory strategy and inputs into future development plans
• Responsible for incorporating and negotiating the regulatory activities, specifications, and
• Responsible for timely delivery and accurate communication, decision making and recommendations for

🎯 Requirements

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

🎁 Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance and 401(k) to eligible employees
• Eligible to participate in long-term incentive programs