Regulatory Affairs, Associate
2 months ago
Job Summary
Working within Regulatory Affairs, reporting to Head, Regulatory Affairs, Associate, Quality & Regulatory Affairs is responsible for performing the required tasks related to Regulatory Affairs.
Principal Responsibilities
**Regulatory Affairs**:
Coordinate with the Export department the regulatory and quality documents required for product registration.
Ensures that the documentation required for regulatory activities is complete, accurate and current.
Coordinates documentation requests from Export with other departments involved (as required) and ensures the information is current, accurate and complete within the established timelines.
Keep abreast of any changes to Guidelines, Regulations, coordinate communication, training and implementation thereof.
Pharmacovigilance (PV), in collaboration with third party vendor, as needed:
Perform literature search and screening on a defined, regular basis.
Prepare Annual Summary Reports
Submission of expedited single cases to Health Canada. Collection, follow-up and forwarding of spontaneous, literature, solicited, post-marketing adverse event cases, ensure local safety data quality control.
Planning and Processing of Aggregate Reports.
Preparation and Implementation of new and updated PV Agreements.
Support PV Awareness and Training. Develop and maintain of PV SOPs.
**Complaints and Queries**:
Coordination of Adverse reaction reports with relevant departments (e.g., QA, Customer Service, Export, PV third party vendor) to help compile adequate feedback to patients and healthcare professionals, as well as redirect and process adverse events cases, as appropriate.
Requirements - Academic, Experience
Bachelor of Science, B.Sc., (e.g., Biochemistry, Pharmacology, Biology)
Minimum 2 years’ experience within Regulatory Affairs, in order to be able to work as independently as possible.
Familiar with local, regional and any other relevant legislation and guidelines regarding Regulatory (e.g., Health Canada, ICH, USP) and PV (e.g., Health Canada), to fulfill duties.
Other Criteria
Fluency in both French and English, written and oral.
Computer literacy and working knowledge of MS Office suite and Adobe Acrobat.
Effective problem-solving approaches to solve Regulatory and PV issues, while seeking endorsement from Director and/or Manager when necessary.
Must be able to communicate efficiently with his/her colleagues.
Ability to review relevant source documentation with attention to detail and accuracy, while managing multiple tasks and prioritizing work in order to meet strict deadlines.
-
Associate, Regulatory Affairs
2 months ago
Montréal, QC, Canada Endo International Full timeJob Description Summary At Paladin Pharma, 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 hybrid work environment, Paladin is the place for you! This position...
-
Regulatory Affairs Associate
7 months ago
Montréal, Canada Allphase Clinical Research Inc. Full timeCalian 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-day regulatory activities? If so, we would love to hear from...
-
Associate, Regulatory Affairs
7 months ago
Montréal, Canada Endo International Full timeJob 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 hybrid work environment, Paladin is the place for you! This position requires a...
-
Fsp - Regulatory Affairs Associate
7 months ago
Montréal, Canada Calian Full timeCalian 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-day regulatory activities? If so, we would love to hear from YOU! Location -...
-
Regulatory Affairs Compliance Associate
7 months ago
Montréal, Canada Novartis Full time395204BR **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 deliver our innovative treatments to patients. As a compliance lead, you will report directly...
-
Regulatory Affairs and Political Analysis Advisor
3 months ago
Montréal, QC, Canada Ubisoft Full time**Company Description** Ubisoft’s 19,000 team members, working across more than 30 countries around the world, are bound by a common mission to enrich players’ lives with original and memorable gaming experiences. Their commitment and talent have brought to life many acclaimed franchises such as Assassin’s Creed, Far Cry, Watch Dogs, Just Dance,...
-
Regulatory Affairs Specialist
6 months ago
Montréal, Canada SeeSpine Full time**About us** We are professional, agile, and innovative. Our work environment includes: - Modern office setting - Food provided - Modern office setting - Growth opportunities - Wellness programs - Work-from-home days Job Summary: We are seeking a highly skilled and motivated Regulatory Affairs Specialist to join our team. As a Regulatory Affairs...
-
Manager, Regulatory Affairs
1 day ago
Montréal, Canada Knight Therapeutics Inc. Full time**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 health products. This includes: i. Evaluating the available data (chemistry/...
-
Regulatory Affairs Specialist
7 months ago
Montréal, Canada Novartis Full time**Summary**: Location: Montreal, #LI-Hybrid About the role: The role reports to Regulatory Affairs Franchise Lead and will work with different team members. Temporary - 9 to 12 months **About the Role**: **Key Responsibilities**: - Assists in the preparation of and/or review of various regulatory submissions for new or marketed products and ensures optimal...
-
Regulatory Affairs Analyst
6 days ago
Montréal, Canada L'Oreal Full timeL'Oréal Canada is looking for a Regulatory Affairs Analyst in Montreal. This role is a contractual opportunity within our Scientific & Regulatory Affairs department. **Main responsibility**: **Responsibilities summary**: - Support marketing with their scientific communications. - Ensure regulatory compliance of formulas, labels and other technical...
-
Regulatory Affairs Specialist
7 months ago
Montréal, Canada Vision Group Full time**See if you are our next**: **BILLINGUAL REGULATORY AFFAIRS SPECIALIST (Operating Room Experience Required)** Working at Vision Group's head office is working for the North American leader in vision correction. It means being able to concretely contribute to the development of the company and support more than 12 brands and more than 70 clinics across...
-
Regulatory Affairs Assistant
6 months ago
Montréal, Canada Innovaderm Research Full timeThe 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 signatures of regulatory forms (i.e., QIU, FDA1572, financial disclosure forms)...
-
Regulatory Affairs Specialist
7 months ago
Montréal, Canada vitaltracer Full timeWork 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 methods and organization of an establishment - Develop quality management and quality...
-
Regulatory Affairs Specialist
7 months ago
Montréal, Canada vitaltracer Full timeWork Term: Permanent - Work Language: English - Hours: 42 to 44 hours per week - Education: Master's degree - Experience: 5 years or more **Tasks**: - Analyze and provide advice on the managerial methods and organization of an establishment - Conduct quality audits - Develop quality management and quality assurance standards - Conduct research to determine...
-
Intern, Regulatory Affairs
4 days ago
Montréal, Canada Cogeco Communications Inc. Full timeOur culture lifts you up—there is no ego in the way. Our common purpose? We all want to win for our customers. We aim to always be evolving, dynamic, and ambitious. We believe in the power of genuine connections. Each employee is a part of what makes us unique on the market: agile and dedicated. - Time Type: Student (Fixed Term) - Job Description: -...
-
Associé.e en Réglementation/regulatory
6 months ago
Montréal, Canada Zoetis Full timeLe rôle principal de l’associé(e) en réglementation - graphiste consiste à gérer la création et les révisions des maquettes pour les produits de santé animale. La personne titulaire du poste interagit directement avec les chefs de marque, des Affaires réglementaires, de l’Assurance qualité et de la Logistique. Ses fonctions administratives...
-
Analyste, Affaires Réglementaires regulatory
3 months ago
Montréal, QC, Canada Keurig Dr Pepper Full timeJob Overview: **Analyste, Affaires réglementaires** permenant, temps plein Montreal, hybride, 3 jours/semaine Lorsque vous travaillez chez KDP Canada, vous plongez au cœur des opérations internes de la troisième plus grande entreprise de boissons au Canada et vous visez un impact positif avec chaque boisson. Vous apprenez comment l'un des 100...
-
Analyste, Affaires Réglementaires regulatory
2 months ago
Montréal, QC, Canada Keurig Dr Pepper Full time**Analyste, Affaires réglementaires** permenant, temps plein Montreal, hybride, 3 jours/semaine Lorsque vous travaillez chez KDP Canada, vous plongez au cœur des opérations internes de la troisième plus grande entreprise de boissons au Canada et vous visez un impact positif avec chaque boisson. Vous apprenez comment l'un des 100 meilleurs employeurs...
-
Director, Legal Affairs
4 months ago
Montréal, QC, Canada PSP Investments Full timeABOUT US We’re one of Canada’s largest pension investment managers, with CAD$264.9 billion of net assets as at March 31, 2024. We invest funds for the pension plans of the federal public service, the Canadian Forces, the Royal Canadian Mounted Police and the Reserve Force. Headquartered in Ottawa, PSP Investments has its principal business office in...
-
Head Government Affairs
4 days ago
Montréal, Canada Core Healthcare Full timeLead the development and execution of government and public affairs strategies, working closely with the provincial and federal government - Shape the public and health policy environment, R&D, production, international trade, finance and fiscal policy - Stay on top of changing political dynamics and government policies, identify emerging external challenges...