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

• Responsible for regulatory strategy development and execution.
• Manages interface with Health Authority (FDA) for key projects.
• Serves as primary liaison with FDA for meetings and teleconferences.
• Advises internal customers on Regulatory/FDA issues.
• Demonstrates excellent negotiation and problem-solving skills.
• Operates independently with minimal direction.
• Coordinates regulatory submissions consistent with US and Canada requirements.
• Ensures compliance with established policies and best practices.
• Presents regulatory information to cross-functional areas.
• Acts as a subject matter expert for Regulatory.

Requirements

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

Benefits

• Comprehensive benefits package including medical, dental, and vision insurance.
• Paid time off including vacation, holidays, and sick leave.
• Participation in short-term and long-term incentive programs.