Regulatory Affairs Co-op

2 weeks ago

Toronto, Canada Johnson & Johnson Full time

**Job Function**:
Career Programs
**Job Sub Function**:
Non-LDP Intern/Co-Op
**Job Category**:
Career Program
**All Job Posting Locations**:
Toronto, Ontario, Canada

**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.

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.
- 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.

**#LI-Hybrid**:

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