Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada

📋 Description

• Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area
• 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
• Key contributor responsible for the preparation and review of regulatory submissions consistent
• Supports the regulatory submission and approval process. Broadly applies regulatory/technical
• Recommends and implements changes to difficult projects based on knowledge and expertise, accurate

🎯 Requirements

• Required Education: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry
• Preferred Education: Advanced Degree a plus. Certifications a plus
• Required Experience: Minimum of 6 years of experience in regulatory affairs, research and
• Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
• Demonstrates effective communication skills in written and oral channels both within Regulatory and
• Able to deliver challenging messages effectively without compromising important business

🎁 Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• long-term incentive programs