Regulatory Compliance Specialist

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, Consumer Products, and Medical Devices.
• Completion of product and site license compliance review and submissions under Health Canada’s applicable regulations (Health Canada and CFIA) within required timelines.
• Ongoing evaluation of change control notifications for regulatory compliance with cross functional departments.
• Evaluate, prepare and submit product and site license applications, notifications and amendments.
• 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 :

• Complete all aspects of product and site license compliance as per Canadian regulations for Foods, Cosmetics, NHPs and Medical Devices including submissions and pre-submission research where applicable.
• 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 review new products within required timelines.
• Preparation of new product labels, ensuring current and ongoing regulatory requirements are met.
• Revisions and release of product labels as required.
• Respond to Health Canada information request notices (IRNs) relating to product or site licensing.
• Correspondence with regulatory agencies on compliance related matters.
• Maintains product quality and regulatory documentation including tracking of licensing applications.
• Record keeping as required.
• Occasional heavy lifting (up to 50 lbs.) of labels required.
• Perform other duties as assigned.

Required qualifications, education, experience, training, skills, background, and certifications :

• Post-secondary education preferably in the area of nutrition, chemistry or human biology
• Proven 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
• Good communication skills with particular skill in writing scientific reports and corresponding with regulatory agencies
• Familiarity with Health Canada’s food, drug and natural health product regulations and GMPs
• Knowledge of Canadian nutraceutical and natural health products industry
• Proven attention to detail, demonstrated through education, training or employment in inspection, research, data collection / management or comparable environment
• Advanced computer skills (MS-Office suites, Oracle Applications)
• Demonstrated ability to work independently on projects and tasks in a well-organized manner to meet deadlines
• Teamwork skills

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.