Regulatory Affairs Specialist

MDA Edge; Calgary; On-site; CAD 80,000 - 110,000; Full time

Job summary

A leading company in regulatory affairs is seeking a detail-oriented Regulatory Affairs Specialist to ensure compliance with Canadian regulations. The role involves managing submissions, liaising with regulatory agencies, and supporting quality assurance initiatives. Candidates should possess a related bachelor's degree and have over 3 years of experience in the industry, along with strong organizational and communication skills.

Qualifications

• 3+ years of experience in regulatory affairs within the related industry.
• Strong knowledge of Health Canada regulations and compliance requirements.
• Familiarity with GMP, GCP, and ISO standards is an asset.

Responsibilities

• Prepare and manage regulatory submissions to Health Canada.
• Ensure compliance with Food and Drugs Act and industry-specific regulations.
• Collaborate with cross-functional teams to meet regulatory requirements.

Skills

Organizational skills

Communication skills

Problem-solving skills

Education

Bachelor's degree in Life Sciences

Bachelor's degree in Pharmacy

Bachelor's degree in Chemistry

Bachelor's degree in Biomedical Engineering

Tools

Microsoft Office Suite

Regulatory submission software

Job description

Job Summary: We are seeking a detail-oriented and experienced Regulatory Affairs Specialist to join our team in Canada. The successful candidate will be responsible for ensuring compliance with Canadian regulatory requirements for our products, working closely with internal teams and regulatory agencies to facilitate approvals and maintain compliance.
Key Responsibilities:

• Prepare, submit, and manage regulatory submissions to Health Canada and other relevant authorities.
• Ensure compliance with applicable Canadian laws, regulations, and guidelines, including the Food and Drugs Act, Medical Devices Regulations, Natural Health Products Regulations, and other industry-specific requirements.
• Maintain up-to-date knowledge of regulatory requirements and communicate any changes to internal teams.
• Assist in the development, review, and approval of labeling, advertising, and promotional materials to ensure regulatory compliance.
• Liaise with Health Canada and other regulatory agencies as necessary for product registrations, licensing, and renewals.
• Support quality assurance and compliance initiatives, including audits, inspections, and risk assessments.
• Prepare and maintain regulatory documentation, including technical files, regulatory dossiers, and product safety reports.
• Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure regulatory requirements are met throughout product development and commercialization.
• Provide training and guidance to internal teams on regulatory affairs processes and requirements.

Qualifications & Experience:

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering, or a related field.
• 3+ years of experience in regulatory affairs within the pharmaceutical, medical device, biotechnology, cosmetics, or natural health products industry.
• Strong knowledge of Health Canada regulations, including experience with regulatory submissions, product licensing, and compliance requirements.
• Familiarity with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and ISO standards is an asset.
• Excellent organizational, communication, and problem-solving skills.
• Ability to manage multiple projects and meet deadlines in a fast-paced environment.
• Proficiency in Microsoft Office Suite and regulatory submission software.

Preferred Qualifications:

• Regulatory Affairs Certification (RAC) is a plus.
• Experience with international regulatory affairs (e.g., FDA, EMA) is beneficial.
• Bilingual (English/French) is an asset.