Regulatory Affairs Analyst

TipTopJob - CA - Jobboard; Mississauga; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading global healthcare company is seeking a Regulatory Affairs Analyst to ensure compliance with Health Canada's regulations. The role involves preparing regulatory submissions, managing labelling, and ensuring product safety. Candidates should possess a Bachelor's Degree and relevant experience in regulatory affairs.

Qualifications

• Minimum 1+ years of hands-on experience in regulatory submission preparation.
• Experience in labelling and clinical trials preferred.
• Good knowledge of Health Canada drug & device regulations.

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

Document management

Education

Bachelor’s Degree

Tools

Vault RIM

eCTD

Job description

Location:

Mississauga - Peel, Ontario, Canada

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Fashion, Art & Design Jobs

Other Industries & Skills:

• Advertising, Marketing & PR
• Engineering
• Finance, Banking & Insurance
• Health, Nursing & Social Services
• Information Technology
• Legal
• Media
• Science

Job ID:

131921404

Posted On:

17 May 2025

The Position

Are you passionate about regulatory compliance and ensuring the safety of medical products? Do you have experience 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 Role:

• Prepare and obtain approval for post-approval submissions, clinical trial applications, and medical device registrations with 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

• 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, analyze, 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 expanding our commitment, reaching millions worldwide and impacting over 40 million patient lives daily. We are one of the 20 most valuable companies in the world by market cap, with more than 72,000 employees globally. We value diverse perspectives and skills, and strive to create an inclusive culture. Join us! Together, we go further. Together, we’re life changing.

Contact

To apply, click "Apply now," attach your CV, and follow the instructions. For more info, follow us on LinkedIn: Novo Nordisk on LinkedIn.

Deadline

Apply before May 23rd, 2025.

Our Commitment

We promote an inclusive recruitment process and equal opportunity for all applicants. We believe in creating a diverse and inclusive culture that celebrates the backgrounds, perspectives, and communities of our employees, patients, and partners. Together, we’re life changing.