Head of Regulatory & Quality - Biotechnology

Yorktown Search Partners; Toronto; Hybrid; CAD 120,000 - 160,000; Full time

Job summary

A leading biotechnology company in Toronto is seeking a Head of Regulatory & Quality to lead regulatory strategy and ensure compliance with international standards. This senior role requires over 10 years of experience in regulatory affairs and quality assurance within biotechnology or life sciences. Responsibilities include engaging with Health Canada and overseeing quality systems. Position is hybrid, offering a pivotal role in securing approvals and positioning for acquisition.

Qualifications

• 10+ years of experience in regulatory affairs and quality assurance within biotechnology.
• Proven success leading products through approval processes with Health Canada or FDA.
• Deep knowledge of GMP / GLP standards.

Responsibilities

• Lead regulatory strategy and engagement with relevant agencies.
• Establish and maintain GMP and GLP quality systems.
• Oversee regulatory filings and approvals for biotech applications.

Skills

Regulatory strategy

Quality assurance

Communication skills

GMP / GLP standards

Job description

Head of Regulatory & Quality

Confidential job posting by Yorktown Search on behalf of a confidential client

Location: Toronto, ON (Hybrid)

Overview

A leading biotechnology company is seeking a Head of Regulatory & Quality to strengthen credibility with regulators, partners, and investors. This senior leader will design and execute the organizations regulatory strategy, ensure compliance with international standards, and oversee quality systems that support commercialization. The role is central to positioning the company as transaction-ready and as a trusted partner for multinational collaborators.

Key Responsibilities

• Lead regulatory strategy and engagement with Health Canada, FDA, EMA, and other relevant agencies.
• Establish and maintain quality systems, including GMP, GLP, and documentation frameworks for biotech commercialization.
• Oversee regulatory filings, safety studies, and approvals for supplements, consumer products, and pharma-grade applications.
• Collaborate with R&D to align data collection with regulatory requirements.
• Provide regulatory insight during licensing negotiations, joint ventures, and due diligence.
• Serve as the primary point of contact for external advisors, regulators, and prospective buyers on compliance and quality.

Qualifications

• 10+ years of experience in regulatory affairs and quality assurance within biotechnology, life sciences, or related industries.
• Proven success leading products or ingredients through approval processes with Health Canada, FDA, or EMA.
• Deep knowledge of GMP / GLP standards and global compliance frameworks.
• Experience supporting M&A, licensing, or capital markets transactions from a regulatory perspective is strongly preferred.
• Excellent communication skills with the ability to translate regulatory complexity into commercial clarity.

Why This Role

Play a decisive role in de-risking innovations, securing approvals, and positioning the platform as a credible acquisition target within global life sciences and consumer health markets.

Application Process

To apply, please submit your resume. Only those selected for an interview will be contacted.