Position Title: Regulatory Affairs, Compliance & Global Launches Specialist

Location: Brampton, Ontario (On-Site)

Employment Type: Permanent Full-Time

Salary Range: $55,000 - $70,000

Work Schedule: Monday to Friday | 9:00 AM – 5:30 PM

Work Location Flexibility: The successful candidate will initially work from the Company's Head Office in Brampton. However, the primary work location may be changed to the Company's Pickering facility or another Company location based on business requirements and operational needs.

Role Description: The Regulatory Affairs, Compliance & Global Launches Specialist is responsible for leading regulatory strategy, product registrations, compliance activities, and market launch execution across Medical Devices, Natural Health Products (NHPs), Pharmaceuticals, and Cosmetics.

Serving as a regulatory subject matter expert, the incumbent will work closely with Quality, Operations, Supply Chain, PMO, Commercial, Marketing, Product Development, and other cross-functional teams to ensure products are registered, compliant, and successfully launched across Canada and international markets.

The role requires a regulatory professional capable of proactively managing regulatory risks, interpreting evolving global requirements, supporting business growth, and driving successful submissions, approvals, compliance initiatives, and market expansion activities.

Preferred Industry Experience: Demonstrated Regulatory Affairs and Compliance experience within the Medical Device industry is strongly preferred. Experience within Natural Health Products (NHPs), Pharmaceuticals, and/or Cosmetics is also highly desirable and considered a valuable asset.

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, 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 ensure regulatory requirements are integrated throughout the product lifecycle.
- Assess the regulatory impact of formulation changes, packaging modifications, labeling updates, manufacturing transfers, and current product development projects.
- Review and approve product claims, labeling, 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 while developing mitigation plans and practical business solutions.
- Maintain regulatory databases and systems to ensure accurate tracking of licenses, 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 / 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 considered an asset.
- Minimum 4+ years of progressive Regulatory Affairs and Compliance experience within Medical Devices, Natural Health Products, Pharmaceuticals, Cosmetics, or other regulated healthcare industries.
- Demonstrated experience managing Health Canada submissions and registrations,



with working knowledge of FDA, EU, UK, and other international regulatory frameworks.
- Strong knowledge of MDSAP requirements, Medical Device Regulations, GMP, ISO 13485, pharmaceutical regulations, NHP regulations, cosmetic regulations, labeling, and post-market compliance requirements.
- Proven track record of successfully leading product registrations, regulatory approvals, and global product launches while managing multiple concurrent projects and timelines.
- Excellent regulatory writing, technical documentation, project management, stakeholder management, and cross-functional collaboration skills.
- Strong analytical, risk assessment, communication, and problem-solving abilities, with the capacity to influence decision-making and drive compliance in a fast-paced environment.

Qualifications

- Strong foundation in Regulatory Affairs, Regulatory Compliance, Product Registration, and Market Access.
- Demonstrated experience managing regulatory submissions, registrations, amendments, renewals, and market authorizations.
- Strong knowledge of Medical Device, NHP, Pharmaceutical, and Cosmetic regulatory requirements.
- Proven experience working with Health Canada and familiarity with international regulatory authorities and frameworks.
- Experience supporting MDSAP, medical device licensing, post-market compliance, audits, and regulatory inspections.
- Demonstrated ability to assess regulatory risks and develop practical mitigation strategies.
- Strong understanding of product labeling, claims, artwork, technical documentation, and regulatory change management.
- Excellent communication, stakeholder management, project management, and relationship-building capabilities.
- Ability to work on-site in Brampton, ON, and effectively collaborate with cross-functional teams.
- Ability to work effectively in a fast-paced, cross-functional, highly regulated healthcare and manufacturing environment.

Hiring Process

- Nanz Pharma does not use AI in candidate screening or selection — all hiring decisions are human-led.
- Interviewed candidates will be informed of hiring decisions within 45 days.

Why Join Us

Join a collaborative, global team helping build the future of pharmaceutical manufacturing, medical devices, and healthcare innovation. Play a key role in leading regulatory strategy, supporting global product launches, ensuring regulatory compliance, and enabling the company's continued growth and expansion across international markets.

📌 Global Regulatory Affairs & Compliance Specialist (Pickering)
🏢 Nanz Pharma
📍 Pickering