Head of Regulatory & Quality - Biotechnology
Head of Regulatory & Quality - Biotechnology
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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.
Employment Type
Full Time
