Regulatory Affairs Specialist

**Location: Toronto, ON**
**Job Type: Full-Time**

**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 gaining valuable experience on the **consulting side**, supporting real-world regulatory submissions 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 Responsibilities**
- **Instruction & Training**:

- Deliver interactive lectures and hands-on workshops in Regulatory Affairs and related areas.
- Teach key regulatory topics such as drug submissions, clinical trial requirements, medical device pathways, labeling, pharmacovigilance, and post-market compliance.
- Create an engaging classroom environment that promotes applied learning and student participation.
- **Course & Curriculum Development**:

- Develop, update, and maintain course content to reflect evolving regulations and best practices.
- Design case studies, projects, and assignments that simulate real-world regulatory challenges.
- Work with academic leadership to ensure programs align with institutional standards and industry needs.
- **Student Support & Mentorship**:

- Provide academic guidance and individualized feedback to students.
- Support learners in exam preparation, applied projects, and professional development.
- Act as a mentor, helping students bridge the gap between classroom learning and industry expectations.
- **Academic Administration**:

- Contribute to student assessments, grading, and reporting in a fair and timely manner.
- Participate in program evaluation and continuous improvement initiatives.
- Support institutional quality assurance processes and adherence to academic policies.

**Consulting Responsibilities**
- **Regulatory Submissions**:

- Ensure submissions meet Canadian, US, and international requirements.
- Maintain accurate and compliant documentation throughout submission cycles.
- **Regulatory Research & Analysis**:

- 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 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).
- **Minimum 3+ years of professional experience** in regulatory affairs within pharmaceuticals, biopharma, 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, 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**
- 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: $65,000.00-$75,000.00 per year

Work Location: I