Health Regulatory Affairs Specialist m/w

As a family-owned company since 1968 — NOW produces high-quality natural and organic products in supplements, essential oils, foods, personal care beauty and more. A part of the NOW Health Group, founded in 1989 and built on a reputation of trust and dependability, Puresource distributes natural products to over 3,000 independent and national retailers across Canada from three warehouses in Alberta, BC and Ontario. With over 3,400 natural & organic wellness products to choose from, we deliver full-service solutions to support brands to grow their business in Canada. Our mission is to provide Canadians with natural products to optimize their health. To do this, we support our brands and retail customers with market leadership and exceptional customer service. The measure of our success is built on the growth of our partners and dedicated teams that create great customer experiences every day.

Senior Regulatory Compliance Specialist

Evaluation of new and existing product compliance for sale in the Canadian market based on current regulatory requirements for Natural Health Products (NHPs), Foods, Cosmetics, and Consumer Products.
Ongoing evaluation of change control notifications for regulatory compliance with cross functional departments.
Evaluate, prepare and submit NHP product and site license applications, notifications, amendments and renewals.
Participation in third party certification and compliance programs.
Coordination with third party vendors on Canadian regulatory compliance for domestic and/or imported products.
Correspondence and participation with appropriate domestic and international regulatory agencies (Health Canada, CFIA, FDA) regarding compliance issues including but not limited to complaints and audits.
Maintains quality operations by following quality policies and standard operating procedures.

Coordinate and maintain Site License Applications (SLAs) and renewals for manufacturing, packaging, labelling, and importing activities.
Ensure ongoing compliance with Health Canada’s NHP Regulations, Good Manufacturing Practices (GMPs), and relevant guidance documents.
Review and approve product labels and advertising to ensure compliance with the Food and Drugs Act, NHPR, and Canadian labelling standards.
Monitor regulatory changes and proactively assess their impact on products and operations.
Develop and implement strategies for timely approvals of NHPs and site licenses.
Serve as the primary contact with Health Canada for NHP-related inquiries and responses to Information Request Notices (IRNs) or Clarification Requests.
Provide guidance and mentorship to junior regulatory staff.
Review of new product formulations for compliance with applicable regulations for NHPs, Foods or Cosmetics in Canada.
Preparation and submission of cosmetic notifications and amendments.
Creation and revision of internal product specifications in compliance with regulatory requirements.
Work with cross functional departments including R&D, Purchasing, Quality, Marketing and Production to align product development with regulatory requirements.
Preparation of new product labels, ensuring current and ongoing regulatory requirements are met.
Maintains regulatory documentation and timelines including tracking of licensing applications.
Required qualifications, education, experience, training, skills, background, and certifications:

• Bachelor’s degree in the area of nutrition, pharmaceuticals, chemistry, human biology or related field. Master’s degree is an asset.
• Proven experience managing multiple NPN submissions, site license renewals and label compliance.
• Experience with Health Canada’s online product licensing systems.
• Knowledge or experience with USP or other pharmacopeial monographs an asset
• Ability to decipher and interpret/understand scientific studies, formulations and reports.
• In depth knowledge of Health Canada’s food, drug and natural health product regulations, GMPs and guidance documents.
• Strong analytical, project management, teamwork and communication skills.
• Advanced computer skills (MS-Office suites, Oracle Applications)
• Demonstrated ability to work independently on multiple projects and tasks in a well-organized manner to meet deadlines.
• Detail oriented and committed to ensuring compliance and quality.

Please note, emails need to have the Job Title (Senior Regulatory Compliance Specialist) in the subject line.