Hybrid Regulatory Affairs Specialist – Quality Assurance

at NAOS

• Job title: Regulatory Affairs Specialist – Quality Assurance
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: CA$70,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Montreal, Canada

About the role

• Regulatory Affairs Specialist ensuring compliance for cosmetics and OTC products. Collaborating with internal teams and managing submissions to Health Canada and FDA at NAOS in a hybrid work environment.

Responsibilities

• Ensure product compliance (cosmetics/OTC/DIN/PSN) with applicable Canadian and U.S. regulatory standards, at both federal and state levels
• Ensure annual renewal of establishment licences for drugs and natural health products
• Develop regulatory strategies
• Prepare documentation and submissions to Health Canada and the FDA: cosmetic notifications, DIN and PSN applications (Canada), and OTC submissions (USA)
• Monitor regulatory developments through professional cosmetics associations (Cosmetic Alliance, PCPC) and liaise with the NAOS Campus regulatory department (France)
• Communicate and implement action plans
• Interpret and communicate regulatory requirements; provide recommendations to internal teams and headquarters (R&D, Marketing, Supply Chain, Commercial)
• Serve as primary contact with regulatory authorities during inspections, follow-ups, or inquiries
• Develop local cosmetic and OTC artworks in collaboration with Marketing
• Validate cosmetic and OTC artworks
• Collaborate with Quality Assurance: develop and validate specification sheets for OTC components
• Maintain OTC regulatory files
• Communicate and implement any changes affecting OTC products
• Perform other related tasks in support of the Quality Assurance department as needed
• Monitor cosmetovigilance and pharmacovigilance
• Report RID information to Health Canada and/or the FDA.

Requirements

• Bilingual French/English (written and spoken)
• Good knowledge of Canadian and U.S. regulations for cosmetics and over-the-counter medicines
• 3 years' experience in Regulatory Affairs
• Three years of university-level studies in a scientific field
• Quality Assurance experience is a plus
• Knowledge of Quality principles
• Ability to work independently and reliably
• Ability to provide guidance and recommendations
• Problem-solving skills
• Ability to manage multiple projects simultaneously
• Strong organizational and communication skills

Benefits

• Remote work (1 day of telework per week)
• 25 days of vacation
• Health insurance coverage
• Comprehensive onboarding with product training
• Flat hierarchy with strong emphasis on personal initiative
• Strong team spirit
• Open, collegial company culture