Regulatory Affairs Specialist

Regulatory Affairs Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Specialist based in Canada.

This role offers the opportunity to play a central part in ensuring products meet Canadian regulatory requirements throughout their lifecycle. You will manage regulatory submissions, product registrations, renewals, and ongoing compliance activities with Health Canada and other relevant authorities. Working cross-functionally, you will partner with R&D, manufacturing, quality, and marketing teams to embed regulatory requirements into product development and commercialization. You will also monitor regulatory changes and translate complex requirements into clear guidance for internal stakeholders. The position combines regulatory expertise, documentation, stakeholder management, and problem-solving in a fast-paced environment. Your work will directly support compliant product launches, successful approvals, and ongoing product quality and safety. It is an excellent opportunity for a regulatory professional looking to broaden their impact across Canadian life sciences and related regulated industries.

Accountabilities:

• Prepare, submit, track, and maintain regulatory applications and submissions to Health Canada and other applicable Canadian regulatory authorities.
• Ensure products and business activities comply with relevant Canadian legislation, regulations, standards, and regulatory guidance, including the Food and Drugs Act, Medical Devices Regulations, and Natural Health Products Regulations.
• Monitor regulatory developments and communicate changes, implications, and required actions to internal stakeholders.
• Support the preparation, review, and approval of product labeling, advertising, claims, and promotional materials to ensure regulatory compliance.
• Liaise with Health Canada and other regulatory agencies regarding product registrations, licenses, submissions, renewals, and regulatory inquiries.
• Support quality and compliance activities, including audits, inspections, risk assessments, corrective actions, and other regulatory initiatives.
• Prepare, organize, and maintain regulatory documentation, including technical files, dossiers, product registrations, and product safety reports.
• Collaborate with R&D, manufacturing, quality, marketing, and other cross-functional teams to integrate regulatory requirements throughout product development and commercialization.
• Provide regulatory guidance and training to internal teams, helping stakeholders understand applicable requirements and compliance processes.
• Manage multiple regulatory projects simultaneously, ensuring accurate documentation, timely submissions, and adherence to applicable deadlines.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering, or a related discipline.
• 3+ years of professional experience in regulatory affairs within the pharmaceutical, medical device, biotechnology, cosmetics, natural health products, or a related regulated industry.
• Strong working knowledge of Canadian regulatory requirements and practical experience with Health Canada submissions, product licensing, registrations, and compliance activities.
• Familiarity with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and ISO standards is an asset.
• Strong regulatory writing, documentation, organizational, communication, and problem-solving skills.
• Ability to interpret complex regulatory requirements and communicate them clearly to technical and non-technical stakeholders.
• Proven ability to manage multiple projects, prioritize competing deadlines, and maintain attention to detail in a fast-paced environment.
• Proficiency with Microsoft Office Suite and regulatory submission or document-management platforms.
• Experience working collaboratively with cross-functional teams and external regulatory stakeholders.
• Regulatory Affairs Certification (RAC) is considered an advantage.
• Exposure to international regulatory frameworks, such as FDA or EMA requirements, is beneficial.
• Bilingual English/French communication skills are an asset.

Benefits

• Opportunity to contribute to regulatory strategy and compliance across products in a regulated Canadian environment.
• Full-time professional opportunity based in Canada.
• Collaborative, cross-functional working environment involving regulatory, quality, R&D, manufacturing, and commercial teams.
• Opportunities to expand expertise across Canadian regulatory frameworks and potentially international requirements.
• Professional development and exposure to evolving regulatory standards and industry practices.
• Opportunity to work on projects spanning product development, registration, commercialization, and lifecycle compliance.
• Equal-opportunity environment committed to diversity, inclusion, professional development, and team empowerment.
• Competitive compensation and employment conditions aligned with the role, experience, and location.