Job Description

Who we are:

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. We are a respected leader in the natural products industry, with a mission to provide products and services that empower people to lead healthier lives.

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. Puresource is proud to be your dedicated Canadian partner in the natural products channel.

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.

Job Title:

Senior Regulatory Compliance Specialist

Location:

In-person, onsite in Guelph, ON

Scope for the position:

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.

Duties and Responsibilities:

Prepare, submit, and manage Product License Applications (PLAs) and amendments for NHPs. Coordinate and maintain Site License Applications (SLAs) and renewals for manufacturing, packaging, labelling, and importing activities. Manage Class I, II, and III submission pathways, including compendial and non-compendial applications. 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. Facilitate product recalls or incident reporting as required under serious adverse reaction reporting obligations. 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. Conduct literature searches in support of natural health product safety and efficacy. Compile and submit research findings to Health Canada in support of product licensing requirements. 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. Perform other duties as assigned.

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. 5+ years of demonstrated experience with Canadian NHP regulations and licensing. Proven experience managing multiple NPN submissions, site license renewals and label compliance. Experience with Health Canada's online product licensing systems. Strong research skills, particularly literature reviews. 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. Knowledge of Canadian nutraceutical and natural health products industry 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.

How to apply:

Qualified candidates can apply through Indeed, LinkedIn or submit their resumes to jobs@puresource.ca. Please note, emails need to have the Job Title (Senior Regulatory Compliance Specialist) in the subject line.

Our Human Resources Team will be in touch if your qualifications match our needs. Please be advised that due to the high volume of applications, only candidates that have been selected for next steps will be contacted.

For more information about our company, visit https://www.puresource.ca/ or https://nowfoods.ca/

For a full list of opportunities, visit https://www.puresource.ca/careers/

Job Types: Full-time, Permanent

Benefits:

Dental care Employee assistance program Extended health care Life insurance On-site parking Paid time off RRSP match Vision care
Ability to commute/relocate:

Guelph, ON: reliably commute or plan to relocate before starting work (required)
Application question(s):

What are your salary expectations?
Work Location: In person