At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, metabolic and chronic diseases. Motivated by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.com/canada for more information.
We offer a work culture that is open, creative, and performance driven with an environment that is fun and sophisticated. Within our facilities we have a fitness center that you can access and an online company store, exclusive to employees, where you can purchase J&J products. We also offer opportunities for employees to get involved in sports teams, social events and to volunteer with local charities.
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.
As a Regulatory Affairs intern, you will:
- Assist in the preparation and compilation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and other submission 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.
- 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.
- Pursuing a Post Graduate Regulatory Affairs Certificate (Hons. Standing)
- 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.
Diversity and inclusion are central elements of the shared culture at Johnson & Johnson. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
About the Company:
Johnson and Johnson