About Us
AAPS College is a premier institution in Canada, committed to advancing education and professional development in the pharmaceutical, biopharmaceutical, or medical device industries. For over 20 years, we have trained professionals and partnered with industry to address complex regulatory and compliance challenges.
This is a unique opportunity to join our team as a Regulatory Affairs Specialist in a dual capacity. You will contribute to our academic programs by teaching, mentoring, and developing content for Regulatory Affairs courses, while also leading consulting projects, supporting real-world regulatory submissions and quality and compliance projects. This hybrid role is designed for professionals who are adaptable, eager to learn, and comfortable wearing multiple hats in a dynamic environment.
Key Responsibilities
Academic & Instruction
- Deliver interactive lectures and hands-on workshops in Regulatory Affairs and related areas.
- Teach key regulatory requirements for drug, medical device and NHP submissions, clinical trials, labelling, pharmacovigilance/device vigilance, and post-market compliance in North America and Europe.
- Create an engaging classroom environment that promotes applied learning and student participation.
- Update and maintain course content to reflect evolving global regulations. Design practical case studies, projects, and assignments that simulate real-world industry challenges.
- Provide academic guidance, individualized feedback, and professional mentorship to help students successfully bridge the gap between classroom learning and industry expectations.
- Conduct fair and timely student assessments, grading, and reporting. Participate in program evaluations and support institutional policies.
Consulting & Regulatory Affairs
- Lead or Assist in with the preparation, review, and filing of regulatory applications (e.g., NDS, ANDS, CTA, IND, DMF, 510(k), etc.) ensuring full compliance with Health Canada, FDA, and international standards.
- Maintain accurate and compliant documentation throughout submission cycles.
- Conduct research on international regulatory frameworks, emerging requirements, and policy changes.
- Prepare summaries, guidance documents, and regulatory intelligence reports for internal and client use.
- Compliance & Quality Assurance Projects
- Support audits, gap assessments, and compliance improvement initiatives.
- Assist in developing or develop SOPs, quality documentation, and corrective/preventive action plans (CAPAs).
- Collaborate with cross-functional teams to ensure deliverables are client-ready and meet industry standards.
- Client Communication & Project Coordination
- Collaborate with clients, internal teams, and stakeholders to manage timelines and deliverables.
- Participate in client meetings, prepare status updates, and support follow-up activities.
- Provide professional, solution-oriented communication that reinforces trust and reliability.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field (Master’s preferred).
- Previous diploma or certificate in Regulatory Affairs and Quality Assurance is preferred.
- Minimum 3+ years of professional experience in regulatory affairs within pharmaceuticals, biopharma, and/or medical devices.
- In-depth understanding of Canadian, US, and/or international regulatory frameworks, guidance documents, and approval processes.
- Strong written and verbal communication skills, including technical writing and document editing.
- Excellent organizational and project management skills, with the ability to balance multiple priorities.
- Teaching, training, or mentoring experience is an asset, but not mandatory.
- Demonstrated flexibility, adaptability, and problem-solving ability in fast-paced environments.
- Proficiency in Microsoft Office, document management systems, regulatory publishing software, and project tracking tools.
Key Competencies
- High attention to detail and commitment to accuracy.
- Ability to simplify complex regulatory concepts for teaching and client communication.
- Professionalism and discretion in handling sensitive information.
- Strong interpersonal skills with the ability to collaborate across diverse teams.
- Self-motivated, proactive, and eager to grow professionally.
What We Offer
- A rare opportunity to work across education and consulting, applying your expertise in both academic and professional contexts.
- Professional development, mentorship, and exposure to diverse regulatory projects.
- A collaborative and supportive team culture where your contributions make an impact.
- Opportunities for long-term career growth, including leadership roles in teaching and consulting projects.
Pay: $75,000.00-$90,000.00 per year
Work Location: In person
