Top Benefits
About the role
WE'RE HIRING
Position Title- Clinical Specialist
Department- Regulatory Affairs
Contract- 1 Year
Address: 16750 Trans-Canada Hwy, Kirkland, Quebec H9H 4M7
Hybrid – 2 days – flexibility on days when team meet
Top Skills
- Bilingual (French)
- Clinical submission to health Canada
- Regulatory Affairs specialist
- Clinical trial application – would be great
- New drug submissions to health Canada experience
- Compliance focused
- 2 years plus experience
Brief Description of Position The Specialist Clinical, Regulatory Affairs is responsible for all Clinical submission requirements for their assigned product portfolio. The Specialist is the Regulatory contact with local stakeholders and Global Regulatory Affairs and effectively collaborates with the other Regulatory Clinical and CMC colleagues.
Qualifications, Skills & Experience
The incumbent must have a University Degree, B.Sc. or higher in Health Sciences or equivalent. The individual is expected to have strong communication and time management skills and the ability to work independently with minimal supervision.
Functional Competencies
• Awareness of Health Canada Food and Drug Act and Regulations and ability to interpret
• Knowledge of Regulatory Affairs science, concepts, and terminology
• Knowledge of the local operating procedures
• Understanding of company Global Regulatory Affairs organization, processes, and compliance expectations
• High level understanding and ability to interpret Health Canada Regulatory requirements and Guidance Documents that impact Clinical-related submissions
Major Activities and Responsibilities
• Project Management lead of regulatory projects related to federal submissions, (e.g., NDSs, SNDSs, PSURs, RMPs) for an assigned list of products.
• Preparation of Regulatory submissions and follow up with Health Canada until final Health Canada Regulatory decision. This includes interacting with Health Canada and being a primary contact with Health Canada with regards to the submissions.
• Ensures that all activities in relation to the registration of new products and their maintenance on the Canadian market are in compliance with the Food and Drugs Act and Regulations, all relevant Canadian guidelines, and The Company policies.
• HC requests (e.g., safety signal assessment, requests for information, ATI) are immediately assessed, communicated to management & Global & managed as a priority & within required timelines.
• Safety Label Updates, PSUR, RMP filings are managed, as per local and global procedures.
• Filing and maintenance of CTA submissions with Health Canada, working in collaboration with Clinical Research (GCTO) colleagues and in compliance with local and global procedures.
• The incumbent will complete their tasks in a manner fully consistent with The Company’s commitment to its Code of conduct, Our Values and Standards, policies, procedures, industry standards and all Laws and Regulations. This includes the obligation to report all AEs and PQCs as per The Company policy, “Know to Report” Pharmacovigilance training, and Health Canada Regulations.
Skills
Communication Skills
• Bilingual French and English (written and oral)
• Ability to communicate effectively verbally and in writing
• Knowledge of Good Documentation Practices
Computer Skills
• Excellent word processing, presentation, and spreadsheet application skills
• Familiar with the use of a large compliance databases
• Ability to learn new computer interface systems
Personal
• Excellent time management, organizational and planning skills
• High level of accuracy and quality in work
• Excellent collaboration and teamwork skills
• Compliance mindset/focused
• Courage and candor
About Amyantek
Amyantek is a Premier IT recruiting company with a focus on the Canadian Market. Our goal is to provide the highest quality of service to both our clients and our professional candidates No matter what the requirement, Amyantek is committed to exceeding our clients needs with the best quality of candidates who are pre- qualified with integrity and honesty at a cost effective solution. We are continuously looking for new ways to provide candidates who fit the complete requirements requested by our clients.
Our services which distinguishes us to our clients • Response to client within 8 hours • Candidate submission within 48 hours of receiving request • Resume submission to request= 3:1 • Contractor Replacement guarantee: 10 days • Full time replacement Guarantee: 90 days
Top Benefits
About the role
WE'RE HIRING
Position Title- Clinical Specialist
Department- Regulatory Affairs
Contract- 1 Year
Address: 16750 Trans-Canada Hwy, Kirkland, Quebec H9H 4M7
Hybrid – 2 days – flexibility on days when team meet
Top Skills
- Bilingual (French)
- Clinical submission to health Canada
- Regulatory Affairs specialist
- Clinical trial application – would be great
- New drug submissions to health Canada experience
- Compliance focused
- 2 years plus experience
Brief Description of Position The Specialist Clinical, Regulatory Affairs is responsible for all Clinical submission requirements for their assigned product portfolio. The Specialist is the Regulatory contact with local stakeholders and Global Regulatory Affairs and effectively collaborates with the other Regulatory Clinical and CMC colleagues.
Qualifications, Skills & Experience
The incumbent must have a University Degree, B.Sc. or higher in Health Sciences or equivalent. The individual is expected to have strong communication and time management skills and the ability to work independently with minimal supervision.
Functional Competencies
• Awareness of Health Canada Food and Drug Act and Regulations and ability to interpret
• Knowledge of Regulatory Affairs science, concepts, and terminology
• Knowledge of the local operating procedures
• Understanding of company Global Regulatory Affairs organization, processes, and compliance expectations
• High level understanding and ability to interpret Health Canada Regulatory requirements and Guidance Documents that impact Clinical-related submissions
Major Activities and Responsibilities
• Project Management lead of regulatory projects related to federal submissions, (e.g., NDSs, SNDSs, PSURs, RMPs) for an assigned list of products.
• Preparation of Regulatory submissions and follow up with Health Canada until final Health Canada Regulatory decision. This includes interacting with Health Canada and being a primary contact with Health Canada with regards to the submissions.
• Ensures that all activities in relation to the registration of new products and their maintenance on the Canadian market are in compliance with the Food and Drugs Act and Regulations, all relevant Canadian guidelines, and The Company policies.
• HC requests (e.g., safety signal assessment, requests for information, ATI) are immediately assessed, communicated to management & Global & managed as a priority & within required timelines.
• Safety Label Updates, PSUR, RMP filings are managed, as per local and global procedures.
• Filing and maintenance of CTA submissions with Health Canada, working in collaboration with Clinical Research (GCTO) colleagues and in compliance with local and global procedures.
• The incumbent will complete their tasks in a manner fully consistent with The Company’s commitment to its Code of conduct, Our Values and Standards, policies, procedures, industry standards and all Laws and Regulations. This includes the obligation to report all AEs and PQCs as per The Company policy, “Know to Report” Pharmacovigilance training, and Health Canada Regulations.
Skills
Communication Skills
• Bilingual French and English (written and oral)
• Ability to communicate effectively verbally and in writing
• Knowledge of Good Documentation Practices
Computer Skills
• Excellent word processing, presentation, and spreadsheet application skills
• Familiar with the use of a large compliance databases
• Ability to learn new computer interface systems
Personal
• Excellent time management, organizational and planning skills
• High level of accuracy and quality in work
• Excellent collaboration and teamwork skills
• Compliance mindset/focused
• Courage and candor
About Amyantek
Amyantek is a Premier IT recruiting company with a focus on the Canadian Market. Our goal is to provide the highest quality of service to both our clients and our professional candidates No matter what the requirement, Amyantek is committed to exceeding our clients needs with the best quality of candidates who are pre- qualified with integrity and honesty at a cost effective solution. We are continuously looking for new ways to provide candidates who fit the complete requirements requested by our clients.
Our services which distinguishes us to our clients • Response to client within 8 hours • Candidate submission within 48 hours of receiving request • Resume submission to request= 3:1 • Contractor Replacement guarantee: 10 days • Full time replacement Guarantee: 90 days