Associate Director Regulatory Affairs

We are seeking an experienced and proactive Associate Director of Regulatory Affairs to lead our regulatory strategy, ensuring compliance with domestic and international regulatory requirements. This role will oversee product registrations, regulatory submissions, labeling compliance, and stakeholder engagement with regulatory bodies. The ideal candidate brings deep expertise in Canadian and international regulations for Natural Health Products (NHPs), dietary supplements, functional foods, or cosmetics.

As Associate Director of Regulatory Affairs, you will be instrumental in shaping our compliance culture, bringing safe and effective products to market, and ensuring our continued growth globally.

Key Responsibilities

Regulatory Strategy & Compliance

• Lead the development and execution of regulatory strategies for all product categories (NHPs, supplements, OTCs, functional foods, cosmetics, etc.).
• Ensure compliance with all applicable Health Canada, FDA, and international regulatory requirements.
• Monitor, interpret, and communicate regulatory changes, trends, and risks across global markets.
• Provide strategic guidance during product development to ensure regulatory feasibility and efficient approvals.

Health Canada & Global Submissions

• Oversee all regulatory submissions including NHP licenses, site licenses, amendments, and renewals with Health Canada.
• Manage international product registrations (e.g., US FDA dietary supplements, EU regulations, etc.).
• Liaise with regulatory authorities to facilitate approvals and resolve issues.

Labeling, Claims & Advertising

• Approve product labels and marketing materials for regulatory compliance (Health Canada, CFIA, FTC, FDA, etc.).
• Review and guide the substantiation of health claims and ingredient safety dossiers.
• Partner with Marketing, Legal, and Product Development to align innovation with compliant messaging.

Team Leadership & Collaboration

• Lead, mentor, and develop a high-performing regulatory team.
• Collaborate cross-functionally with Product Development, R&D, Marketing, Quality Assurance, and Operations.
• Represent Regulatory Affairs in strategic planning, portfolio reviews, and innovation discussions.

Risk Management & Continuous Improvement

• Develop internal policies, SOPs, and compliance training programs.
• Lead regulatory audits and support quality/regulatory inspections.
• Evaluate and recommend risk mitigation strategies related to market entry, compliance, and labeling.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Pharmacy, or related field (Master’s or Regulatory Certification an asset).
• 8–10+ years of progressive experience in Regulatory Affairs, preferably within natural health products, supplements, or food/COS sectors.
• 3–5 years in a leadership role, managing teams and cross-functional initiatives.
• Strong working knowledge of Health Canada (NHP Regulations), FDA, CFIA, FTC, and international regulatory frameworks.
• Experience with global submissions and market expansions (especially US and EU).
• Demonstrated success in regulatory strategy, label review, and regulatory body communications.
• Exceptional leadership, communication, and organizational skills.
• Detail-oriented, solution-driven, and able to manage multiple projects in a fast-paced environment.

Why work for Organika?

Working with us means you will belong to a team of driven individuals who thrive in a versatile and ever-changing environment. We are on a journey to achieve our vision of being the #1 guide for natural health in Canada and we are looking for individuals who are genuinely excited about this! 

Certified as a Great place to Work and a Diversity Equity Inclusion Workplace we are serious about providing an environment that supports happy, healthy, and hungry individuals achieve their personal and professional dreams. With over 70% of our team holding nationalities outside of Canada, and the ability to speak over 25 different languages, we are a team that welcomes everyone. 

Aside from being a part of a globally recognized brand, we offer some great benefits and perks such as: access to an on-site RHN, yoga, guided mediation, professional development allowance, fitness reimbursements, mat-leave top-up, regular social events, product discounts... just to name a few.