Regulatory Affairs Manager
2 weeks ago
Clinical, Medical & Regulatory DepartmentMississauga, CanadaAre 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 roleAs 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 QualificationsWe 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 departmentAs 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.
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Regulatory Affairs Manager
1 week ago
Mississauga, Ontario, Canada Novo Nordisk, Inc. Full time $80,000 - $120,000 per yearRegulatory Affairs ManagerCategory: Reg Affairs & Safety PharmacovigilanceLocation:Mississauga, Ontario, CAClinical, Medical & Regulatory DepartmentMississauga, CanadaAre 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...
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Regulatory Affairs Manager
2 weeks ago
Mississauga, Canada Novo Nordisk Full timeClinical, Medical & Regulatory DepartmentMississauga, CanadaAre 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...
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Regulatory Affairs Manager
1 week ago
Mississauga, Canada Novo Nordisk Full timeClinical, 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...
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Regulatory Affairs Manager
1 week ago
Mississauga, Canada Novo Nordisk Full timeClinical, 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...
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Regulatory Affairs Manager
2 weeks ago
Mississauga, Ontario, Canada Novo Nordisk Full time $80,000 - $120,000 per yearClinical, Medical & Regulatory DepartmentMississauga, CanadaAre 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...
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Regulatory Affairs Associate
2 days ago
Mississauga, Canada Bayer Full time**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
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Specialist, Regulatory Affairs
1 hour ago
Mississauga, Ontario, Canada Ipsen Full time US$60,000 - US$1,000,000 per yearSummaryAs a Specialist, Regulatory Affairs, you will be responsible for supporting the Associate Director, Regulatory Affairs and Manager, Regulatory Affairs, as well as submission operations across all therapy areas within the Regulatory Affairs department. This role will have responsibility for a portfolio of projects consisting of activities for approved...
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Regulatory Affairs Analyst
2 days ago
Mississauga, Canada Novo Nordisk Full timeRegulatory Affairs Analyst **Category**:Reg Affairs & Safety Pharmacovigilance **Location**:Mississauga, Ontario, CA **Regulatory Affairs Analyst (15-month contract)** **PURPOSE** - Prepares labelling submissions and manages all aspects of labelling using conventional methods or NNCI's labeling system. Prepares submissions and obtains Health Authority...
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Specialist, Regulatory Affairs
1 day ago
Mississauga, Canada Ipsen Group Full timeCookie NoticeSpecialist, Regulatory Affairs page is loaded## Specialist, Regulatory Affairslocations: Mississaugatime type: Full timeposted on: Posted Todayjob requisition id: R-20294**Title:**Specialist, Regulatory Affairs**Company:**Ipsen Biopharmaceuticals Canada Inc.**About Ipsen:**Ipsen is a mid-sized global biopharmaceutical company with a...
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Specialist, Regulatory Affairs
24 hours ago
Mississauga, Canada Ipsen Group Full timeCookie NoticeSpecialist, Regulatory Affairs page is loaded## Specialist, Regulatory Affairslocations: Mississaugatime type: Full timeposted on: Posted Todayjob requisition id: R-20294**Title:**Specialist, Regulatory Affairs**Company:**Ipsen Biopharmaceuticals Canada Inc.**About Ipsen:**Ipsen is a mid-sized global biopharmaceutical company with a focus on...
