Regulatory Affairs Specialist

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.