Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada

📋 Description

• Development and implementation of US and Canada regulatory strategic and tactical planning (RSTP)
• Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates
• Functions independently in negotiation and decision-making for project related issues that have
• Responsible for preparation and review of regulatory submissions consistent with US and Canada
• Supports the regulatory submission and approval process
• Recommends and implements changes to difficult projects based on knowledge and expertise

🎯 Requirements

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology or industry related
• Advanced Degree a plus
• Minimum of 6 years of experience in regulatory affairs, research and development, or related
• At least 2-3 years of experience performing pharmaceutical regulatory activities
• Excellent negotiation skills and problem solving skills
• Effective communication skills in written and oral channels

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Participation in long-term incentive programs