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Regulatory Affairs Excellence Lead (Market Access & Licensing)

Nanz Pharma
1 day ago
On-site
Brampton, ON, Canada
Indeed

Position Title: Regulatory Affairs Excellence Lead (Market Access & Licensing) Location: Brampton, Ontario Work Location: Head Office – Brampton, Ontario Employment Type: Full-Time Work Schedule: Monday to Friday | 9:00 AM – 5:30 PM Salary Range: $80,000 - $100,000 Company Description: Nanz Pharma is a globally respected Canadian healthcare company specializing in the development and manufacturing of medical devices, pharmaceuticals, and Natural Health Products (NHPs). With a strong focus on innovation, quality, and regulatory excellence, the organization is committed to delivering safe, effective, and affordable healthcare solutions that improve the quality of life for people around the world. Driven by a culture of integrity, accountability, and continuous improvement, Nanz Pharma partners with customers, healthcare professionals, and communities to develop products that meet high global quality and compliance standards. The company's vision is to provide trusted healthcare solutions built on quality, innovation, and excellence, while fostering an environment where talented professionals can contribute to meaningful advancements in healthcare and long-term global growth. Job Summary: The Regulatory Affairs Excellence Lead (Market Access & Licensing) provides strategic and operational leadership for regulatory affairs, licensing, product registrations, market access, and commercialization activities across Medical Devices, Natural Health Products (NHPs), Pharmaceuticals, and Cosmetics . Serving as the organization's regulatory authority, this role is responsible for developing and executing global regulatory strategies, securing and maintaining product registrations and licenses, managing regulatory risk, and ensuring compliance with applicable Health Canada, FDA, EMA, MHRA, TGA, ANVISA, PMDA, MDSAP, and other international regulatory requirements governing the lifecycle of regulated products. As a company operating as both a manufacturer and Contract Manufacturing Organization (CMO), this role supports internal product portfolios as well as customer-owned products by enabling successful product commercialization, international market expansion, and regulatory approvals across multiple jurisdictions. The incumbent collaborates closely with Quality, Operations, Supply Chain, PMO, Commercial Excellence, and Executive Leadership teams to support new product introductions, customer onboarding, technology transfers, market-entry initiatives, licensing activities, and global product launches while maintaining a proactive regulatory intelligence and compliance framework that supports sustainable business growth, customer success, and accelerated speed to market. Preferred Industry Experience: Demonstrated regulatory leadership experience within the Medical Device industry is strongly preferred. Experience within Natural Health Products (NHPs) and/or Pharmaceuticals is also highly desirable and considered a valuable asset. Experience supporting Contract Manufacturing Organization (CMO), private-label, technology transfer, or multi-product environments is considered an asset. Key Responsibilities: Lead regulatory submissions, approvals, renewals, amendments, maintenance, and lifecycle management for MDL, MDEL, NPN, Site Licences, DEL, Cosmetic Notifications, Export Certificates, Certificates of Free Sale, and global market authorizations. Develop and execute regulatory, market access, and commercialization strategies supporting product registration, lifecycle management, market penetration, and international expansion across Medical Devices, NHPs, Pharmaceuticals, and Cosmetics. Serve as the primary company representative and regulatory liaison with Health Canada, FDA, EMA, MHRA, TGA, ANVISA, PMDA, and other domestic and international regulatory authorities. Conduct regulatory pathway assessments, product classification reviews, jurisdictional feasibility evaluations, and market-entry analyses to identify optimal registrat…

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