Regulatory Strategist Consultant - CMC

📋 Description

• Support regulatory strategy and execution across product lifecycle.
• Develop and implement CMC regulatory strategies.
• Prepare and review CMC submissions for US FDA and Health Canada.
• Manage Modules 1-3 and coordinate with DMF holders.
• Lead post-approval activities and FDA IR/CRL responses.
• Collaborate cross-functionally with CMC, QA, and manufacturing.

🎯 Requirements

• Bachelor’s in Pharmaceutical Sciences, Chemistry, or related field.
• 3+ years in CMC regulatory affairs in pharma/biotech/CDMO.
• Hands-on U.S. FDA and Health Canada CMC submissions experience.
• Knowledge of ICH guidelines, FDA and Health Canada requirements.
• Experience with Modules 1-3 and DMFs.
• Able to manage multiple submissions and timelines.

🎁 Benefits

• Hybrid work option in Canada.
• 12-month contract with renewal.
• Global CRO with focus on quality and development.
• Cross-functional collaboration across CMC, QA, and Manufacturing.