Regulatory Affairs Co-Op

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Regulatory Affairs Co-Op to be in Toronto, ON.

• The Co-op term is from August 2025, to July, 2026.
• Full time requirement (37,5 hours per week).
• Flexible working model (2 days remote / 3 days in office).

Purpose:

The 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.

You will be responsible for:

• 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 / Requirements:

• Completion of Undergraduate Freshman year at accredited University is required.
• The applicant will have a Bachelor’s degree in the biological or life sciences. An advanced university degree (Masters, 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 is 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 is highly desirable.
• Knowledge of 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.
• The ability to interpret and summarize clinical data, summarize Real World Evidence and basic biostatistics is highly desirable.

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.

Johnson and 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 email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

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