Regulatory Affairs Co-Op

Johnson & Johnson Innovative Medicine•Toronto, ON

2d•Hybrid

About The Position

The Co-op term is from July, 2026 to June, 2027. Full time requirement (37.5 hours per week). Flexible working model (2 days remote / 3 days in office). 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.

Requirements

Completion of Undergraduate Freshman year at an accredited University is required.
The applicant will have a Bachelor’s degree in the biological or life sciences.
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).

Nice To Haves

An advanced university degree (Masters, PhD) in Biological Sciences (Therapeutic, Clinical, Pharmacology or related fields) is preferred.
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.

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.