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Regulatory Affairs Technician
1 week ago
Glanbia Nutritionals Saint-Hubert, CanadaAFFICHAGE INTERNE · TECHINICIEN(NE AFFAIRES RÉGLEMENTAIRES · **Statut**: Permanent, temps plein · **Lieu**: Saint Hubert · **DESCRIPTION DU POSTE**: · Relevant du superviseur des affaires réglementaires, le rôle du technicien(ne) affaires réglementaires est de: · - Rédiger et pro ...
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Regulatory Affairs Consultant(E) Affaires
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BML Health Inc. Montréal, Canada**English to follow.** · **Consultant(e) en affaires réglementaires - Technologies émergentes - Dispositifs médicaux** · **A propos de BML Santé** · BML Santé est une entreprise mondiale de services de technologie de la santé située à Montréal, au Canada. BML Santé a été fondée p ...
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Regulatory Affairs Assistant
2 days ago
Innovaderm Research Montreal, Canada PermanentThe Regulatory Affairs Assistant is responsible for handling regulatory documents and maintaining the Investigator's Study Files (ISFs) for all studies at the clinical research unit. · RESPONSABILITIES · More specifically, the Regulatory Affairs Assistant must: · Track the signat ...
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Regulatory Affairs Associate
3 weeks ago
IFRS Foundation Montréal, Canada**Location**: Beijing (PR of China), Frankfurt am Main (Germany) or Montreal, Quebec (Canada) preferred (office-based role, with flexible, hybrid office/home working offered) · **Duration**: Permanent or fixed term secondment · **Salary**: Competitive, plus benefits · **Hours**: ...
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Regulatory Affairs Assistant
1 week ago
Innovaderm Research Montréal, CanadaThe Regulatory Affairs Assistant is responsible for handling regulatory documents and maintaining the Investigator's Study Files (ISFs) for all studies at the clinical research unit. · **RESPONSABILITIES** · More specifically, the Regulatory Affairs Assistant must: · - Track the ...
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Associate, Regulatory Affairs
3 weeks ago
Endo International Montréal, CanadaJob Description Summary · At Paladin, we strive to offer a work environment that meets the diverse needs of our team members and advances the goals of the individual, the team and the company, while promoting flexibility, accountability and collaboration. If you're looking for a ...
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Regulatory Affairs Associate
1 week ago
Medisca Pharmaceutique Inc Montréal, Canada**Medisca **is a global corporation with locations throughout North America, Australia, and Europe, that contributes to healthcare by leveraging strong partnerships that deliver customized solutions with an unwavering commitment to quality and innovation. Backed by 30+ years and ...
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Regulatory Affairs Specialist
3 weeks ago
vitaltracer Montréal, CanadaWork Term: Permanent · - Work Language: English · - Hours: 38 to 44 hours per week · - Education: Master's degree · - Experience: 5 years or more · - Bioengineering and biomedical engineering · - Mechanical engineering · **Tasks**: · - Analyze and provide advice on the managerial ...
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Regulatory Affairs Specialist
2 days ago
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Manager, Regulatory Affairs
4 days ago
Knight Therapeutics Inc. Montréal, Canada**Role** · This position is based in Montréal; French/English bilingualism, both written and oral, is required. · **Responsibilities**: · 1. Preparing quality regulatory submissions according to Health Canada standards and predefined timelines for drugs, biologics and natural hea ...
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Regulatory Affairs Associate
1 week ago
Allphase Clinical Research Inc. Montréal, CanadaCalian CRO is looking for a Regulatory Affairs Associate on behalf of our client for a limited 12-month term contract with a possibility of renewal. The role will be primarily remote, with occasional attendance in the Montreal office for meetings. Do you have a passion for day-to ...
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Regulatory Affairs Compliance Associate
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Novartis Montréal, Canada395204BR · **Regulatory Affairs Compliance Associate**: · Canada · **About the role** · Location: Montreal, #LI-Hybrid · 13 month contract · About the role: · We are looking for an organized, collaborative and passionate regulatory affairs professional who is driven to help us de ...
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Associate Director Regulatory Affairs
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Fsp - Regulatory Affairs Associate
3 days ago
Calian Montréal, CanadaCalian CRO is looking for a Regulatory Affairs Associate on behalf of our client for a limited 12-month term contract with a possibility of renewal. The role will be primarily remote, with occasional attendance in the Montreal office for meetings. Do you have a passion for day-to ...
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Regulatory Affairs
6 days ago
MY01 Montréal, QC, CanadaLa version française est disponible sur ce lien · Founded in 2019 and based in Montreal, MY01 envisions a world where every disease is quantifiable, enabling precise, personalized care for all patients. Specializing in managing limb ischemia and compartment syndrome, our tools p ...
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Regulatory Affairs Specialist
22 hours ago
Bausch Health Companies Laval, CanadaBausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. · Our team manufactures and markets a wide variety of p ...
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Specialist Regulatory Affairs
6 days ago
Sobeys Montreal-nord, Canada**Requisition ID**:182413 · **Career Group**:Corporate Office Careers · **Job Category**:Food Safety Regulatory Affairs · **Travel Requirements**:0 - 10% · **Job Type**:Full-Time · **Country**:Canada (CA) · **Province**:Québec · **City**:Montréal · **Location**:Bureau de Montréal ...
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Regulatory Affairs Project Leader, Artwork
1 week ago
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Regulatory Affairs Associate
2 weeks ago
MedXL Pointe-Claire, Canada**Regulatory Affairs** **Associate** · **Department**:Quality Assurance · The Regulatory Affairs Associate works to register and maintain registrations of products worldwide with primary emphasis on liaising with regulatory agencies and third parties on all regulatory matters con ...
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Regulatory Affairs Specialist
1 day ago
Acclive Inc Dorval, Canada100% Onsite/Extension/FTE: possibility · Top Qualifications: Regulatory and Product Compliance background, Safety/RF knowledge in Information Technology Equipment (ITE), which means computer hardware · this role is to provide Regulatory support for new product development as well ...
Senior Specialist Regulatory Affairs - Montréal, QC, Canada - Pharmascience
Description
:
The Senior Specialist CMC assumes responsibilities to ensure the completeness of CMC documentation for all product dossiers and timely market approvals.
The ideal candidate is highly organized with a desire and ability for continuous learning, has good communication skills and adapts to changing priorities.
Tasks & Responsibilities:
Plan, manage, and execute the preparation, compilation, filing, and approval of high-quality regulatory submissions for presentation to the relevant Health Authorities for new products and to maintain as well the compliance and life cycle of currently marketed products.
Critical assessment of data and documents to identify gaps compared to regulatory requirements and develop mitigation strategies for discussion with project teams.
Prepare and review of responses to Health Authority requests and Deficiency Letters in timely manner and actively participate in negotiations with Health Authorities to ensure prompt regulatory approvals of dossiers under review and in preparation.
Interact, communicate and negotiate with internal and external stakeholders.Complete regulatory impact assessment of quality/GMP change control requests.
Maintain current awareness of all regulatory guidelines and understand the impact on the department's processes.
Skills, Knowledge and Abilities: 3 to 5 years regulatory work experience.
Ability to interpret and apply regulatory requirements to moderately complex projects.
Advanced working knowledge, drug development, manufacturing, and commercialization of regulated healthcare products (drug products, natural health products, and medical devices if applicable).
Advanced organizational and communication skills (oral and written).Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines in a collaborative manner.
Bilingual (English and French).
Computer literacy:
Microsoft Word, Excel, and Outlook, Adobe Acrobat.
Business Acumen to actively contributes to the department's key performance indicators
Drive Results:
Consistently achieve results even under tough circumstances.
Optimize Work Processes:
Understands departmental and key corporate processes and efficiently performs tasks as per documented processes with a focus on continuous improvement.
Ability to effectively build formal and informal relationship networks inside the organizationGood communication skills
Education
:
Bachelor
Experience
:
3 years:
Experience in Regulatory Affairs
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