Regulatory Affairs Manager

Novo Nordisk; Mississauga; On-site; CAD 100,000 - 120,000; Full time

Job summary

A leading pharmaceutical company in Mississauga is seeking a Regulatory Affairs Manager to ensure compliance and support drug approvals. The role requires a strong background in regulatory affairs, leadership skills, and experience in negotiation with regulatory agencies. Ideal candidates will have a B.Sc. degree and at least 5 years of relevant experience. This is an onsite position in a dynamic and engaging work environment.

Benefits

Opportunities for learning and development

Dynamic and inclusive work environment

Qualifications

• Minimum of 5 years of regulatory affairs experience, preferably in the pharmaceutical or biological industry.
• Experience in interacting with regulatory agencies and negotiating evidence.
• In-depth knowledge of advertising and promotional reviews.

Responsibilities

• Developing product registration applications, including supplements and clinical trials.
• Interacting and negotiating with regulatory agency personnel.
• Acting as a resource and mentor for colleagues.

Skills

Regulatory compliance

Leadership

Negotiation with regulatory agencies

Scientific background

Knowledge of Health Canada regulations

Education

B.Sc. in a relevant field

Job description

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 Regulatory Affairs Manager at Novo Nordisk Canada.

Your new role

As a Regulatory Affairs Manager, you will play a key role in ensuring regulatory compliance and supporting the approval of new drugs, biologics, and medical devices. Your responsibilities will include:

• Developing product registration applications, including supplements, amendments, and clinical trials.
• Interacting and negotiating with regulatory agency personnel to expedite approval of pending registrations submissions and addressing any questions.
• Serving as a regulatory liaison on local and global project teams throughout the product lifecycle.
• Ensuring pre-clinical, clinical, CMC, device, and labelling documentation meet regulatory requirements for timely approvals.
• Supporting or leading promotional material review, in compliance with applicable regulations.
• Maintaining a controlled documentation system and ensuring procedures are in place to classify and retain records.
• Acting as a resource and mentor for colleagues with less experience, while handling specialist tasks of high complexity critical to the department.

Your Skills and Qualifications

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

• A university degree (B.Sc.) in a relevant field.
• A minimum of 5 years of regulatory affairs experience, preferably in the pharmaceutical or biological industry.
• Strong scientific background and in-depth knowledge of advertising and promotional reviews.
• Experience in interacting with regulatory agencies and negotiating evidence.
• Knowledge of Health Canada regulations, guidelines, and policies.

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.

This position is based in the Clinical Medical and Regulatory department at Novo Nordisk Canada. Our team is dedicated to ensuring regulatory compliance, gaining regulatory approval for clinical trials, new drugs, and devices, and expanding the availability of existing products. We also work to safeguard patient safety through pharmacovigilance activities. The department fosters a collaborative and inclusive atmosphere, where you will work alongside talented professionals who are passionate about making a difference in patients' lives. This is an onsite role, offering a dynamic and engaging work environment.

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 novonordisk.com, 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 December 1st, 2025

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.