Regulatory Affairs Intern
Publication date:
25 September 2024Workload:
100%Contract type:
Permanent position- Place of work:Ontario
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/.
Johnson & Johnson Innovative Medicine in Canada is currently recruiting for a Regulatory Affairs Intern to be located in Toronto, Ontario, Canada under the flexible working model (2 days remote + 3 days in office).
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
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.
In this role, you will:
- 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.