Regulatory Affairs Analyst

Novo Nordisk; Mississauga; On-site; CAD 65,000 - 85,000; Full time

Job summary

Novo Nordisk is seeking a Regulatory Affairs Analyst to ensure compliance with Health Canada regulations. The role involves preparing submissions, managing labelling, and assessing regulatory requirements. Join a leading healthcare company dedicated to patient safety and regulatory excellence.

Qualifications

• 1+ years of experience in regulatory submission preparation.
• Experience with Health Canada regulations and labelling.

Responsibilities

• Prepare and obtain approval for regulatory submissions.
• Manage product labelling artwork for compliance.
• Assess regulations for submission requirements.

Skills

Regulatory Compliance

Health Canada Regulations

Labelling

Clinical Trials

Document Management

Education

Bachelor’s Degree

Tools

eCTD

Vault RIM

Job description

Are you passionate about regulatory compliance and ensuring the safety of medical products? Do you have experience in navigating Health Canada’s regulations and guidelines? If so, we invite you to apply for the position of Regulatory Affairs Analyst at Novo Nordisk. Read on and apply today for a life-changing career.

The Position

• As a Regulatory Affairs Analyst, you will:
• Prepare and obtain approval for post-approval submissions, clinical trial applications, and medical device registrations to Health Canada.
• Manage the preparation of mock-up and final product labelling artwork for regulatory submissions and compliance.
• Assess Health Canada regulations and guidelines to determine requirements for regulatory submissions and labelling changes.
• Utilize internal systems (e.g., Vault RIM) for managing regulatory activities and ensuring compliance.
• Handle annual notifications, change control assessments, and provide safety information as requested by Health Canada.

Qualifications

• We are looking for candidates who meet the following criteria:
• Bachelor’s Degree required.
• Minimum 1+ years of hands-on experience in regulatory submission preparation.
• Experience in labelling, preparing clinical trials, and post-approval changes to marketing (Canadian experience preferred).
• Experience with eCTD preparation and some experience with a document management system.
• Good knowledge of Health Canada drug & device Regulations, guidances, and policies.
• 1-2 years of regulatory affairs experience.
• Nice to have:
• Knowledge in the biomedical or biology industry.

About the Department

The Regulatory Affairs and Safety Pharmacovigilance team in Canada is dedicated to ensuring regulatory compliance and safeguarding patient safety. Our team is responsible for gaining regulatory approval for clinical trial applications, new drugs, devices, and digital health products, while expanding the availability of existing products. We actively engage with health authorities and policymakers to shape future regulatory frameworks. With a focus on product safety, we collect, analyse, and report safety data, continuously monitoring for new safety signals. Join us in our mission to ensure medicines are safe to use and to maintain our license to operate in a fast-paced and dynamic environment.

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognise the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing.

Contact

To complete your application, please click "Apply now" attach your CV and follow the instructions.For more information, please follow us on LinkedIn: Novo Nordisk: About | LinkedIn

Deadline

Apply before May 23rd 2025.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.