CMC Regulatory Affairs Intern
$5,741,600–$7,535,850 year
HybridMississauga, Ontario, Canada
Job Summary
Generate and submit high-quality CMC regulatory documents to global health authorities while ensuring strict adherence to current Good Manufacturing Practices (cGMP) and applicable health authority requirements. Coordinate cross-functional deliverables to manage product lifecycles, monitor project milestones, and keep team leads informed of submission risks and strategic impacts. Identify operational efficiencies to contribute to continuous improvement initiatives across regulatory processes and support quality system maintenance and inspection readiness activities. This 12-month full-time internship begins January 2027 in Mississauga, ON, with a hybrid schedule requiring a minimum of three days in the office.
Required Qualifications
- Currently pursuing a Master's program in Biotechnology, Biomedical Discovery and Commercialization, or a related field
- Solid foundational understanding of the biotechnology/pharmaceutical industry and drug manufacturing processes
- Strong written and verbal communication skills with an ability to present clear technical information
- Proactive problem solver with a structured, analytical approach to gathering data and making decisions
- Strong organizational abilities
- Learning agility
- Collaborative mindset
- Minimum 3 days in office (Hybrid model)
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