Manager Regulatory Affairs, Global Regulatory Strategy US & Canada - Hybrid

Manager leading regulatory strategy and implementation for US and Canada markets at a pharmaceutical company. Develops tactical plans for approved and investigational products, manages FDA communications, and ensures compliance with regulatory requirements across therapeutic areas.

Responsibilities

• Develop and execute regulatory strategy and tactical plans for assigned products
• Serve as FDA liaison for routine communications and support filing submissions
• Prepare and review regulatory submissions ensuring compliance with US and Canada requirements
• Advise internal teams on regulatory and FDA matters across functions
• Interpret and apply government regulations, guidance, and corporate policies to projects

Requirements

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related field
• 6+ years regulatory, R&D, or industry-related experience
• Proven ability to implement US and Canada regulatory strategies
• Experience interfacing with regulatory agencies such as FDA
• Strong written and oral communication skills
• Demonstrated negotiation skills and consensus-building ability
• Ability to work effectively in complex matrix environments