Regulatory Affairs Associate

Who are we?
Organika is a premium natural health company from Vancouver, Canada. We have been obsessed with helping people live healthier for over 35 years now! As trendsetters in the health industry, we strongly believe everyone should have accessibility to natural wellness solutions. We are award-winning innovators, whose collective commitment is to offer the highest-quality standards and put our customers first.

About the Role
We are looking for a detail-oriented and proactive Regulatory Affairs Associate to join our growing team in Vancouver.

In this role, you will support the regulatory compliance of our natural health products throughout their lifecycle, from product development and licensing to labeling and ongoing maintenance. Working closely with the Regulatory Affairs Manager and cross-functional teams, you will prepare and maintain regulatory submissions, coordinate product licensing activities with Health Canada, review product labels and supporting documentation, and help ensure compliance with applicable regulatory requirements and Good Manufacturing Practices (GMP).

This is an excellent opportunity for someone with hands-on regulatory experience who enjoys problem-solving, working collaboratively across departments, and navigating an evolving regulatory landscape. You'll play an important role in supporting product innovation while helping maintain the quality, safety, and integrity of Organika's products.

Key Responsibilities

1. Regulatory Submissions & Product Licensing
   • Prepare, review, and submit Natural Health Product (NHP) licence applications, amendments, and notifications (Class I, II, and III).
   • Coordinate and manage correspondence with Health Canada regarding product licence applications, Information Request Notices (IRNs), and other regulatory inquiries.
   • Support domestic and international product registrations by compiling and coordinating required regulatory documentation.
   • Monitor regulatory requirements and provide guidance to internal stakeholders on applicable regulatory standards and changes.
2. Label Review & Product Compliance
   • Support the product label review and approval process, including preparing initial label proformas and coordinating revisions with the Marketing and Innovation teams
   • Maintain and update the product label database to ensure accurate and current regulatory information.
   • Verify supplier documentation and supporting references to ensure product label claims, ingredients, and specifications are appropriately substantiated.
   • Review product and supplier documentation to support compliance with applicable regulatory requirements.
3. Quality & Documentation Management
   • Maintain organized and up-to-date regulatory files, databases, and product documentation.
   • Review key Contract Manufacturing Organization (CMO) documentation to support compliance with applicable Health Canada, CFIA, FDA, and GMP requirements.
   • Assist with regulatory and quality audits by preparing and coordinating requested documentation.
   • Respond to internal and external documentation requests, including Certificates of Analysis (COAs), Halal certifications, product specifications, and other regulatory records.
   • Support customer inquiries related to product documentation and regulatory information.
4. Cross-Functional Support & Continuous Improvement
   • Provide regulatory guidance and support to internal departments, including Quality, Innovation, Marketing, and Operations.
   • Stay current on regulatory developments and requirements from Health Canada, CFIA, the US FDA, and other applicable regulatory bodies.
   • Contribute to continuous improvement initiatives focused on strengthening quality systems, product compliance, and operational efficiency.
   • Perform other related duties as required.

Skills & Qualifications Required

• Bachelor's degree in a scientific discipline, such as Biology, Chemistry, Food Science, or a related field.
• Minimum 2 years of relevant experience in Regulatory Affairs and/or Quality Assurance within a pharmaceutical, biotechnology, food, or natural health product environment.
• Hands-on experience preparing and managing regulatory submissions, preferably Natural Health Product (NHP) licence applications and amendments.
• Experience corresponding with Health Canada regarding product licence applications and regulatory inquiries.
• Working knowledge of Good Manufacturing Practices (GMP) and applicable Health Canada, CFIA, and/or FDA regulatory requirements.
• Experience reviewing product labels, specifications, supplier documentation, and other quality or regulatory records is an asset.
• Strong attention to detail with excellent organizational and document management skills.
• Excellent written and verbal communication skills, with the ability to work effectively with cross-functional teams.
• Strong analytical, problem-solving, and critical-thinking abilities.
• Proficiency in Microsoft Office applications, particularly Excel, Word, and Outlook.
• Ability to manage multiple priorities, meet deadlines, and maintain accuracy in a fast-paced environment.
• Self-motivated and proactive, with the ability to work independently and exercise sound judgment.
• Adaptable, resourceful, and comfortable working with minimal supervision.

Why work for Organika?
At Organika, you'll be part of a passionate team of high-performing individuals who thrive in a dynamic, fast-paced environment where innovation, collaboration, and growth are part of everyday life.

We're on an ambitious journey to become the most trusted consumer health brand in Canada that represents on a global scale. To get there, we're looking for people who are energized by meaningful work, excited by growth, and motivated to make a difference.

As a certified Great Place to Work® and Diversity, Equity & Inclusion Workplace™, we're committed to creating an environment where our people can thrive both personally and professionally. We believe that diverse perspectives make us stronger, and we're proud to have a team representing more than 70 nationalities and speaking over 25 languages. No matter where you're from, you'll find a place to belong here.

Beyond the opportunity to contribute to a globally recognized wellness brand, we offer a range of benefits and perks designed to support your well-being and development, including: access to an on-site RHN, guided meditation classes, professional development funding, fitness reimbursements, maternity leave top-up, regular team socials and health events, employee product discounts, and more!

If you're hungry to learn, passionate about wellness, and driven to grow alongside a company that's making a positive impact on people's lives, we'd love to hear from you.

Apply Now
Please submit your resume and short note about why you are excited about this opportunity and joining Organika! While we may not be able to respond to everyone individually, please know that we truly appreciate the time and effort you put into your application, and we will be in touch with only those successfully selected for next steps.