International Regulatory Affairs Director
Novo Nordisk
Clinical, Medical & Regulatory Department
Are you passionate about regulatory affairs and ensuring compliance in the pharmaceutical industry? If so, we invite you to join our team as Regulatory Affairs Manager at Novo Nordisk Canada.
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. 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.
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.
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. 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. 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.
com, Facebook, Instagram , X , LinkedIn and YouTube. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health.
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