Spécialiste principal (e) clinique, Affaires réglementaires / Senior Clinical Project Manager (Clinical)

Merck•Kirkland, QC

18h•CA$98,560 - CA$147,840•Hybrid

About The Position

The Senior Clinical Regulatory Affairs Specialist is responsible for all Clinical submission requirements for their assigned product portfolio. The Senior Specialist is the Regulatory contact with local stakeholders and Global Regulatory Affairs and effectively collaborates with the other Regulatory Clinical and CMC colleagues. The Senior Specialist is expected to take on other additional activities including projects and leadership of team initiatives.

Requirements

University Degree, B.Sc. or higher in Health Sciences or equivalent.
Strong communication and time management skills and the ability to work independently with minimal supervision.
Minimum of 5 years’ experience and demonstrated success in Regulatory Affairs.
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
Fluency in French is required
Ability to communicate effectively verbally and in writing
Knowledge of Good Documentation Practices.
Excellent word processing, presentation, and spreadsheet application skills
Familiar with the use of a large compliance databases
Ability to learn new computer interface systems
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

Responsibilities

Lead of regulatory projects related to federal submissions, (i.e., NDSs, SNDSs, etc.) 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.
Health Canada requests (safety signal assessment, requests for information, ATI, etc.) are immediately assessed, communicated to management & Global and managed as a priority and 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 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.
Perform other activities as requested by the Director/Associate Director, Clinical.