Regulatory Affairs, Compliance & Global Launches Specialist

Position Title: Regulatory Affairs, Compliance & Global Launches Specialist Location: Brampton, Ontario (On-Site) Primary Work Location: Pickering, Ontario (On-Site) Employment Type: Full-Time Work Schedule: Monday to Friday | 9:00 AM – 5:30 PM Salary Range: $55,000 - $75,000 Company Description Nanz Pharma is a Canadian healthcare company specializing in medical devices, pharmaceuticals, and Natural Health Products (NHPs). The company is committed to delivering patient- and customer-centric healthcare solutions driven by quality, innovation, and partnership. Position Summary The Regulatory Affairs, Compliance & Global Launches Specialist is responsible for leading regulatory strategy, product registrations, compliance activities, and market launch execution across Medical Devices (MDSAP), Natural Health Products (NHPs), Pharmaceuticals, and Cosmetics. This role serves as a regulatory subject matter expert, partnering with cross-functional teams to ensure products are registered, compliant, and launched on time across Canada and international markets. The Specialist proactively manages regulatory risks, interprets evolving global requirements, and drives successful submissions, approvals, and compliance initiatives while supporting business growth and market expansion. Key Responsibilities Lead regulatory submissions, registrations, amendments, renewals, and approvals for Medical Devices, NHPs, Pharmaceuticals, and Cosmetics in Canada and global markets. Develop and execute regulatory strategies to support timely product launches, market expansion initiatives, and commercialization objectives. Serve as the primary regulatory liaison with Health Canada, the FDA, international regulatory agencies, Notified Bodies, and other applicable authorities. Manage medical device regulatory activities, including MDSAP compliance requirements, medical device licensing, registrations, product changes, and post-market obligations. Coordinate and prepare regulatory dossiers, technical files, product registrations, notifications, submissions, and supporting documentation required for market approvals. Partner with Quality, Operations, Supply Chain, PMO, Commercial, and Marketing teams to integrate regulatory requirements throughout the product lifecycle. Assess the regulatory impact of formulation changes, packaging modifications, labelling updates, manufacturing transfers, and new product development projects. Review and approve product claims, labelling, artwork, promotional materials, and technical documentation to ensure compliance with applicable regulations. Monitor global regulatory developments, emerging requirements, standards, and guidance documents, and proactively communicate business impacts and required compliance actions. Lead regulatory due diligence assessments for new products, business opportunities, acquisitions, contract manufacturing partnerships, and market expansion initiatives. Support internal and external audits, regulatory inspections, MDSAP audits, and compliance assessments, including preparation, response coordination, and CAPA follow-up activities. Establish and maintain regulatory compliance processes, procedures, documentation systems, and regulatory intelligence programs. Identify regulatory risks, compliance gaps, and market-entry challenges, and develop mitigation plans and practical business solutions. Maintain regulatory databases and systems to accurately track licences, registrations, certifications, product approvals, renewals, and commitments. Provide regulatory leadership, training, and guidance to internal stakeholders to support a culture of compliance, operational excellence, and successful global product launches. Perform other tasks and assignments as assigned by the Manager or designate. Key Requirements Bachelor’s degree in Science, Pharmacy, Life Sciences, Regulatory Affairs, Biomedical Engineering, Chemistry, or a related discipline. Advanced certification in Regulatory Affairs is…

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