Regulatory and Quality Manager

St-Amour; Montreal; On-site; CAD 90,000 - 120,000; Full time

Job summary

A leading company in pharmaceuticals and Natural Health Products is seeking a Manager, Quality and Regulatory in Montreal. The successful candidate will oversee quality and compliance, manage regulatory submissions, and ensure adherence to industry standards. This role is ideal for a detail-oriented professional looking to impact a dynamic organization significantly.

Qualifications

• Strong understanding of Canadian regulatory landscape and quality requirements.
• Experience with cGMP standards.
• Detail-oriented with strong management skills.

Responsibilities

• Oversee quality and regulatory compliance for Canadian subsidiary.
• Manage product license submissions and regulatory documentation.
• Lead pharmacovigilance activities and training for stakeholders.

Skills

Regulatory Compliance

Quality Assurance

Pharmacovigilance

Cross-functional Collaboration

Product License Submissions

Job description

Our client is a global leader in pharmaceuticals and Natural Health Products. They are currently seeking a Manager, Quality and Regulatory to oversee quality and regulatory compliance for their Canadian subsidiary across Natural Health Products (NHPs), Drugs (DINs), and Cosmetics.

Reporting directly to the Country Manager , with a dotted line to the Head of Pharmaceutical Affairs, North America , the ideal candidate will have a strong understanding of the Canadian regulatory landscape and quality requirements.

In this role, you will lead regulatory, quality, and pharmacovigilance activities to ensure compliance with Health Canada regulations and company standards. You will provide regulatory guidance on product innovations, manage product license submissions, and ensure compliance in labelling and advertising. Collaborating cross-functionally, you will optimize product claims and formulations, oversee the review and approval of packaging and marketing materials, and maintain regulatory documentation. Additionally, you will support the development of clinical content for healthcare professional (HCP) engagement , facilitate training for employees and agencies, and act as the primary regulatory liaison with global headquarters.

In quality management , you will develop and implement policies aligned with regulatory requirements, oversee product inspections and audits, and ensure adherence to cGMP standards . You will work closely with internal teams and external partners to maintain product quality and compliance, manage quality systems, and address deviations and investigations. Additionally, you will support product registration and customer inquiries .

In pharmacovigilance , you will oversee adverse event reporting , guide external vendors managing the PV / AE process, support audit preparations, and provide training on pharmacovigilance to internal and external stakeholders.

This is an excellent opportunity for a proactive and detail-oriented professional to make a meaningful impact in a dynamic and growing organization.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance and Strategy / Planning
• Pharmaceutical Manufacturing

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Manager Quality And • Montreal, Montreal (administrative region), Canada