Regulatory Affairs Excellence Lead (Market Access & Licensing)

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 registration and commercialization strategies.
• Develop and implement global market access strategies supporting distributor onboarding, commercialization, international expansion, and entry into new regulatory jurisdictions.
• Collaborate with Quality Operations, Quality Systems & Compliance, and other cross-functional teams to ensure alignment with regulatory requirements, MDSAP, GMP, licensing obligations, and Quality Management System (QMS) expectations.
• Lead regulatory intelligence activities to monitor emerging regulations, guidance documents, industry trends, regulatory developments, and evolving market requirements.
• Provide regulatory oversight for contract manufacturing, private-label programs, technical transfers, commercialization projects, customer initiatives, and new product introductions.
• Support business growth, customer acquisition, and customer retention by serving as the regulatory subject matter expert for registrations, market access, compliance requirements, and global launch strategies.
• Lead regulatory review and approval of labeling, claims substantiation, promotional and advertising materials, packaging, Instructions for Use (IFUs), product information, and other regulatory content.
• Ensure ongoing regulatory compliance throughout the product lifecycle, including annual reporting, renewals, amendments, notifications, license maintenance, post-market obligations, and regulatory commitments.
• Support importation, exportation, distribution, warehousing, and international supply chain activities through compliance with jurisdiction-specific regulatory requirements.
• Lead regulatory authority interactions during inspections, audits, licensing reviews, compliance assessments, regulatory inquiries, and other regulatory engagements.
• Develop and monitor Regulatory Affairs and Market Access KPIs, dashboards, and performance metrics, including approval timelines, submission success rates, launch readiness, licensing performance, regulatory commitments, and market expansion objectives.
• Build and maintain strong relationships with regulatory authorities, industry associations, distributors, consultants, certification bodies, customers, and internal stakeholders.
• Promote regulatory awareness, inspection readiness, compliance excellence, proactive risk management, and a culture of regulatory accountability throughout the organization.

Key Requirements

• Bachelor’s degree in Regulatory Affairs, Pharmacy, Life Sciences, Chemistry, Biological Sciences, or a related scientific discipline; an advanced degree is preferred.
• Minimum 10+ years of progressive Regulatory Affairs experience, including significant leadership experience within Medical Devices, Natural Health Products (NHPs), Pharmaceuticals, or other regulated healthcare industries.
• Demonstrated success developing and executing regulatory and market access strategies resulting in product registrations, regulatory approvals, international market authorizations, product launches, commercialization, and market expansion across multiple jurisdictions.
• Proven track record obtaining and maintaining MDL, MDEL, NPN, Site Licences, DEL, Cosmetic Notifications, Certificates of Free Sale, Export Certificates, and other domestic and international regulatory authorizations.
• Strong knowledge of global regulatory frameworks, regulatory pathways, product classification, and regulatory authorities, including Health Canada, FDA, EMA, MHRA, TGA, ANVISA, PMDA, GCC, ASEAN, and other international jurisdictions.
• Proven experience supporting new product launches, technology transfers, portfolio expansion, customer onboarding, labeling and claims compliance, advertising regulations, regulatory intelligence, post-market obligations, vigilance requirements, and product lifecycle management.
• Working knowledge of GMP, GDP, ISO 13485, MDSAP, Quality Management Systems (QMS), Risk Management, Change Control, CAPA, Post-Market Surveillance, Vigilance Reporting, and regulatory compliance principles applicable to regulated healthcare products.
• Strong understanding of regulatory submission requirements, licensing frameworks, product classification, market access considerations, and commercialization requirements across multiple jurisdictions.
• Demonstrated ability to manage multiple regulatory projects, prioritize competing business requirements, and deliver submissions and approvals within established timelines.
• Strong leadership, communication, stakeholder management, negotiation, analytical, and problem-solving skills.
• Proven ability to work collaboratively with Quality, Operations, Supply Chain, PMO, Commercial, Sales, and Executive Leadership teams in a fast-paced, cross-functional environment.

Qualifications:

• Strong foundation in Regulatory Affairs, regulatory strategy, product registration, licensing, and market access.
• Demonstrated experience managing regulatory submissions and product lifecycle activities across multiple product categories and jurisdictions.
• Strong knowledge of Canadian and international regulatory requirements applicable to medical devices, pharmaceuticals, NHPs, cosmetics, and other regulated healthcare products.
• Proven ability to interpret regulatory requirements, assess regulatory risk, develop strategic pathways, and provide practical business-oriented regulatory advice.
• Strong project management and organizational skills, with the ability to manage multiple submissions, regulatory projects, and business priorities simultaneously.
• Excellent written and verbal communication skills, including the ability to communicate complex regulatory matters to technical, commercial, operational, and executive stakeholders.
• Demonstrated ability to build effective relationships with regulatory authorities, customers, distributors, consultants, certification bodies, and internal stakeholders.
• Advanced regulatory, quality, or industry certifications are considered an asset.
• Ability to work on-site in Brampton and travel to the Company's Pickering facility or other locations as required by business needs.