Associate Director, RA Global Regulatory Strategy, US & Canada - Remote

Overview

The Associate Director, RA Global Regulatory Strategy, US & Canada is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning for assigned on market products or those products in development.

In Short

• Develop and implement regulatory strategies for US and Canada.
• Manage interface with Health Authority (FDA) for key projects.
• Serve as primary liaison with FDA for meetings and submissions.
• Advise internal teams on regulatory issues.
• Demonstrate strong negotiation and problem-solving skills.
• Operate independently with minimal direction.
• Assist in training and mentoring staff members.
• Coordinate regulatory submissions and responses to Health Authorities.
• Ensure compliance with US and Canada regulations.
• Lead regulatory efforts across therapeutic areas.

Requirements

• Bachelor’s Degree in pharmacy, biology, pharmacology, or related life sciences.
• 8 years of Regulatory, R&D, or Industry-related experience.
• 5 years in pharmaceutical regulatory affairs preferred.
• Excellent written and oral communication skills.
• Extensive experience interfacing with government agencies.
• Ability to deliver challenging messages effectively.
• Experience in a complex and matrix environment.
• Demonstrated success in negotiation and strategic thinking.
• Proven skill in implementing regulatory strategies.

Benefits

• Comprehensive benefits package including paid time off.
• Medical/dental/vision insurance.
• 401(k) eligibility.
• Participation in short-term incentive programs.
• Participation in long-term incentive programs.