Shape regulatory practices as Head of Regulatory & Quality. Focus on compliance with international regulations while overseeing effective quality systems essential for biotechnology success.
This strategic senior role aims to enhance regulatory credibility and facilitate successful commercialization. You will lead regulatory strategies involving Health Canada, FDA, and EMA, ensuring quality systems meet rigorous standards. Key tasks include managing regulatory filings, safety studies, and providing strategic insights during negotiations for partnerships or transactions.
Key Responsibilities:
• Direct regulatory strategy and agency engagement
• Establish and manage GMP/GLP quality systems
• Oversee all aspects of regulatory filings
• Ensure compliance with R&D data collection
• Act as a key contact for compliance discussions
Requirements:
• 10+ years in regulatory affairs and quality control
• Experience with Health Canada, FDA, and EMA approvals
• Knowl...