Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs

Category: Reg Affairs & Safety Pharmacovigilance

Location:Mississauga, Ontario, CA

Clinical, Medical & Regulatory Department

Mississauga, Canada

Are you passionate about regulatory affairs and ensuring compliance in the pharmaceutical industry? Do you have a strong strategic vision and leadership skills to drive in an unordinary way? If so, we invite you to join our team as an Associate Director of Regulatory Affairs at Novo Nordisk Canada.

Your new role

As an Associate Director of Regulatory Affairs, you will play a pivotal role in ensuring regulatory compliance and obtaining Health Authority approvals for our products. You will lead a team of professionals and collaborate with cross-functional teams to drive regulatory strategies and support Novo Nordisk's business goals. Your key responsibilities will include:

• Developing submission strategies and preparing regulatory submissions to Health Canada for clinical trial applications, new drug registrations, and product amendments.
• Participating in Global Regulatory Project Teams (GRPT) to ensure Canadian regulatory requirements are addressed during early development stages.
• Acting as a liaison between Health Canada and Novo Nordisk to ensure regulatory compliance for marketed and clinical trial products.
• Managing and mentoring a team, including hiring, training, performance appraisals, and professional development.
• Representing Novo Nordisk as part of the BIOTECanada BRAG team to collaborate with industry and Health Canada on regulatory and quality guidelines.
• Supporting marketing and sales operations by participating in business teams, conducting promotional reviews, and providing regulatory advice.
• Ensuring compliance with Novo Nordisk policies, procedures, and regulatory requirements.

Your Skills and Qualifications

We are looking for a highly skilled and experienced professional with the following qualifications:

• A university degree (minimum B.Sc.) in a related field.
• 8-10 years of regulatory affairs experience in the pharmaceutical industry, with a strong scientific background.
• Demonstrated experience managing and leading teams.
• Proven track record with Health Canada Pre-Submission Meetings and Health Authority interactions.
• Experience with advertising and promotional reviews.

Your new department

As part of International Operations, you will join our largest operational unit. Covering 194 countries and 95% of the world's population, more than 18,000 of us work passionately to serve 35 million patients each day. With a promise to outperform the competition, we continue to be the growth driver for Novo Nordisk, and to improve health at scale across the globe.

You will be part of the Clinical, Medical & Regulatory team in our Canada Affiliate. Our department is dedicated to ensuring regulatory compliance for new products, product amendments, and safety pharmacovigilance, enabling Novo Nordisk to maintain its license to operate. We work collaboratively to gain regulatory approval for clinical trials, new drugs, devices, and digital health solutions, while also expanding the availability of existing products.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

More information

For more information, visit , Facebook, Instagram, X, LinkedIn and YouTube. To complete your application, click on "Apply now", attach your CV and follow the instructions.

Deadline

Please apply before November 19th, 2025. Please note that applications are reviewed on an ongoing basis, and the position may be closed before the deadline.

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.

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

We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.