Regulatory Affairs Assistant Manager Canada, Wellbeing Collective

Unilever•Toronto, ON

5d•CA$84,900 - CA$127,300

About The Position

This role is for a Regulatory Affairs (RA) Assistant Manager - Canada, within Unilever's Wellbeing Collective Group, focusing on the Canadian Natural Health Products business. The position involves providing regulatory expertise and assessments to ensure compliance with Health Canada’s Natural Health Product (NHP) Regulations. The responsibilities cover the entire product lifecycle, from development and formulation to product license applications, launches, and post-license changes. The role requires close collaboration with various internal stakeholders (R&D, Quality, Legal, Marketing, Brand Management) and external parties such as Regulatory Authorities and Trade Associations. Experience in foods/supplemented foods is preferred.

Requirements

5+ years of direct Canadian natural health product regulatory experience.
Bachelors or Master’s degree in regulatory affairs, science, medical sciences, pharmacology, or an equivalent combination of education and experience.
In-depth knowledge and experience with Health Canada quality & regulatory requirements, applicable laws and regulations, including NHP GMP standards.
Experience in Health Canada NHP regulatory submissions, Foods/Supplemented foods, and product licensing systems.
Technical writing experience in a compliance environment (e.g., microbiology, food science, chemistry, or biochemistry).
Ability to review/complete efficacy and/or safety assessments and dossiers as required for NHP product classification.
Ability to develop and maintain collaborative relationships with peers, colleagues, and internal/external clients.
Strong verbal and written communication skills (including analysis, interpretation, & reasoning).
Ability to work autonomously and within a team in a fast-paced, deadline-oriented environment.
Self-motivated with critical attention to detail, deadlines, and reporting.
Excellent English written and verbal communication skills.

Nice To Haves

Experience in foods/Supplemented foods.

Responsibilities

Liaise between business partners and Health Canada to ensure accurate information and understanding of regulatory requirements for natural health product registrations (product license applications, PLAs).
Work proactively with external partners and support cross-functional delivery teams for complex regulatory projects, including classification assessment, market entry assessment, regulatory query response, and regulatory compliance projects.
Perform product submission classifications for NHPs (Compendial/Class 1, Class 2, or Class 3 submissions) and assess ingredients for acceptability based on product monograph or Class 3 submission evidence.
Maintain products throughout their lifecycle, from development/formulation to post-license changes, keeping business partners informed of potential impacts on product supply/availability.
Collaborate with Global and Regional R&D to ensure all technical and Canadian-specific requirements for natural health products are met.
Review and substantiate marketing and scientific claims appropriate to product classification, and work with R&D on evidence requirements for claims.
Defend products and claims with relevant Health Canada authorities.
Work with legal counsel to resolve labelling conflicts or other issues arising from ambiguity in NHP regulations, applying risk management principles for consumer and brand protection.
Monitor, interpret, and validate the current and changing regulatory landscape, communicating potential impacts on innovation/product maintenance.
Compile and maintain regulatory documentation, ensuring up-to-date records for compliance, including maintaining repositories of current labelling and ensuring proper version control and document integrity.
Work with Quality & R&D to establish release specifications aligned with submitted NHP licenses, and collaborate with importation & QA for Site license and finished product testing requirements, establishing testing per NHP Quality Guidance.