Manager Regulatory CMC Strategy

Overview

Role involves shaping global regulatory CMC strategies and ensuring compliance across product lifecycle.

Ideal candidate has 6+ years in the pharmaceutical industry with strong CMC regulatory authoring experience.

Locations

• Canada
• Romania
• United States
• United Kingdom
• India

Requirements

• Bachelor's degree in a scientific discipline
• At least 6 years of pharmaceutical industry experience
• Minimum 2 years in CMC regulatory authoring

Responsibilities

• Develop and execute regulatory CMC strategies
• Lead resolution of complex issues
• Collaborate with R&D, Quality, and Regulatory Affairs
• Author and review regulatory CMC submissions
• Ensure accuracy and compliance of documentation
• Represent CMC on project teams
• Mentor junior team members

Benefits

• Competitive salary
• Full remote flexibility
• Comprehensive healthcare coverage
• Paid time off
• Opportunities for professional development
• Collaborative work culture