Regulatory Affairs Co-Op – Toronto, ONThe Regulatory Affairs department is responsible for the registration of new pharmaceutical products, new product indications and line extensions and for compliance with Health Canada regulatory requirements for drug products.Responsibilities:Assist in the preparation and compilation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and other submissions to support the lifecycle management of pharmaceutical products.Assist in the development of responses to Health Canada queries in relation to clinical efficacy and safety, clinical pharmacology, biopharmaceutics and preclinical subject matter (e.G., Clarification letters, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]) in a timely manner.Collaborate with internal partners to ensure delivery of regulatory affairs activities to meet strategic business objectives and goals.Assist with the department’s effort to operationalize and improve critical departmental processes.Qualifications:Completion of Undergraduate Junior year at an accredited University is required.Bachelor’s degree in the biological or life sciences; a Master’s, PhD in Biological Sciences (Therapeutic, Clinical, Pharmacology or related fields) is preferred.Enrolled in a Post Graduate Certificate or Degree program related to Regulatory Affairs.Minimum GPA of 2.8.Legally authorized to work in Canada.Strong computer skills,



knowledge of databases and Excel.Strong problem‑solving and analytical skills.Robust 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 the review and approval of drug submissions is highly desirable.Ability to interpret and summarize clinical data, summarize Real World Evidence and basic biostatistics is highly desirable.Compensation:The base pay for this position is Second Year $26.00/hr, Third Year $27.50/hr, Fourth Year $28.50/hr, Post‑graduate degree $32.00/hr. Candidates hired outside Canada will be eligible for compensation and benefits in accordance with their local market. Ineligibility for severance.EEO and Equality Statement: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.Accessibility:Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.Jnj.Com/contact-us/careers or contact AskGS to be directed to your accommodation resource.#J-18808-Ljbffr

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