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 and teleconferences
• Coordinates preparation and completion of FDA meeting briefing packages and responses
• Advises internal customers on Regulatory/FDA issues
• Functions independently in negotiation and decision-making for project issues with crossfunctional
• Preparation and review of regulatory submissions consistent with US and Canada regulatory

🎯 Requirements

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology or industry related
• Advanced degree a plus
• Certifications a plus
• Minimum of 6 years of experience in regulatory affairs or related pharmaceutical industry field
• At least 2–3 years of experience performing pharmaceutical regulatory activities
• Excellent negotiation and problem solving skills

🎁 Benefits

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