Regulatory Affairs Intern

Johnson & Johnson

Sep 25

Applications are closed

Internship
Full-time
Off-cycle Internship
Toronto

Requirements

The applicant will have a Bachelor’s degree in the biological or life sciences. An advanced university degree (MSc, PhD) in biological sciences or life sciences is preferred.
Enrolled in a Post Graduate Certificate or Degree program related to Regulatory Affairs.
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 is highly desirable.
The ability to interpret and summarize Real World Evidence is highly desirable.
The ability to interpret basic biostatistics is highly desirable.
This position is located in Toronto, Ontario.
This position duration is 12 months.

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.

FAQs

What is the duration of the Regulatory Affairs Intern position?

The position duration is 12 months.

Where is the Regulatory Affairs Intern position located?

The position is located in Toronto, Ontario.

What educational background is required for this internship?

The applicant must have a Bachelor’s degree in the biological or life sciences, and an advanced university degree (MSc, PhD) in biological sciences or life sciences is preferred.

Is knowledge of Canadian drug laws and regulations necessary for this position?

Yes, knowledge of Canadian drug laws, regulations, guidelines, and policies is highly desirable.

What type of skills are important for this role?

Strong problem-solving, analytical, teamwork, and communication skills are important, along with project management skills.

Will the intern assist with regulatory submissions?

Yes, the intern will assist in the preparation and compilation of regulatory submissions, including New Drug Submissions (NDSs) and Supplemental New Drug Submissions (SNDSs).

Are there opportunities for collaboration in this role?

Yes, the intern will collaborate with internal partners to ensure delivery of regulatory affairs activities that meet strategic business objectives and goals.

Is scientific writing experience desirable for this internship?

Yes, scientific writing skills are highly desirable for this position.

What is the working model for this internship?

The internship follows a flexible working model of 2 days remote and 3 days in the office.

What types of tasks will the intern perform related to Health Canada?

The intern will assist in developing responses to Health Canada queries related to clinical efficacy and safety and support lifecycle management of pharmaceutical products.

Johnson & Johnson

Hospitals and Health Care

Science & Healthcare

Industry

10,001+

Employees

Mission & Purpose

Profound Change Requires Boldness. Johnson & Johnson is the largest and most diversified healthcare products company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world.