Regulatory Affairs Co‑OpLocation:Toronto, ON, CanadaTerm:July 2026 – June 2027 (Co‑op)Schedule:Full time, 37.5 hours per week; 2 days remote / 3days in office.PurposeThe Regulatory Affairs department is responsible for registration of new pharmaceutical products, recent product indications and line extensions and for compliance with Health Canada regulatory requirements for drug products.You will be responsibleAssist in preparation and compilation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and other submissions to support lifecycle management of pharmaceutical products.Assist in development of responses to Health Canada queries related to clinical efficacy and safety, clinical pharmacology, biopharmaceutics and preclinical subject matter in a timely manner.Collaborate with internal partners to ensure delivery of regulatory affairs activities to meet strategic business objectives and goals.Assist with departmental efforts to operationalize and improve critical departmental processes.Qualifications / RequirementsCompletion of undergraduate freshman year at an accredited university is required.Bachelor’s degree in biological or life sciences; advanced university degree (Masters, PhD) in biological sciences (therapeutic, clinical, pharmacology or related fields)



preferred.Enrolled in a postgraduate certificate or degree program related to Regulatory Affairs.Minimum GPA 2.8 required.Legally authorized to work in Canada.Strong computer skills, knowledge of databases and Excel.Strong problem‑solving and analytical skills.Strong teamwork and communication skills (oral and written); scientific writing skill highly desirable.Project management skills and ability to handle multiple priorities.Knowledge of the drug development process, Canadian drug laws, regulations, guidelines and policies, and the Health Authority organizational structure and processes for drug submission review and approval highly desirable.Ability to interpret and summarize clinical data, summarize real‑world evidence and basic biostatistics highly desirable.Compensation: $26.00/hr to $32.00/hr. Second year $26.00/hr, third year $27.50/hr, fourth year $28.50/hr, post‑graduate degree $32.00/hr.Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.#J-18808-Ljbffr

📌 Regulatory Affairs Co-Op - C$26 - C$32 An Hour - No Experience Required (Winnipeg)
🏢 Johnson & Johnson
📍 Winnipeg