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Chef de projets, Affaires réglementaires (CMC) / Project Manager, Regulatory Affairs (CMC)
Merck
Kirkland, CAN
Full Time
Mid
Hybrid
1 weeks ago
Regulatory AffairsCMC SubmissionsProject ManagementHealth Canada RegulationseCTDTechnical Writing
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Regulatory AffairsCMC SubmissionsProject Management
About the Role
Merck is seeking a Project Manager, Regulatory Affairs CMC to coordinate planning, preparation, and submission of global regulatory Chemical Manufacturing Control submissions. The role involves managing submissions with Health Canada, interfacing with global regulatory partners, and ensuring compliance.
Key Skills for This Role
Regulatory AffairsCMC SubmissionsProject ManagementHealth Canada RegulationseCTDTechnical Writing
Responsibilities
- Coordinate the planning, preparation and submission of global regulatory Chemical Manufacturing Control related submissions, including Marketing Application(s) and post approval changes.
- Ensure that all submissions are complete, accurate and meet relevant requirements, and that they are prioritized and filed so that there is no regulatory impact on supply.
- Management of Chemical Manufacturing Control submissions and follow up with Health Canada until final Health Canada regulatory decision, including interacting with Health Canada and being a primary contact.
- Interface with global Regulatory partners and internal cross functional teams.
- Assess Health Canada requests (i.e. requests for information), communicate to management and Global, manage as a priority and within required timelines.
- File and maintain Clinical Trial Applications submissions (Chemical Manufacturing Control) with Health Canada and ensure compliance with local and global Standard Operating Procedures.
Requirements
- University Degree, B.Sc. or higher in Chemistry or Health Sciences or equivalent.
- Intermediary experience in regulatory affairs or a related function in a pharmaceutical and/or biotechnology company.
- Working Knowledge of Health Canada regulations, guidance and policies, including a high level understanding of the Health Canada regulatory requirements for Chemistry, Manufacturing and Control submissions.
- Excellent time management skills and the ability to work independently with minimal supervision.
- Outstanding interpersonal and communication (written and verbal) skills.
- Proficient with computer and standard software programs, with excellent word processing, presentation and spreadsheet application skills.
- Detail oriented, with a high level of accuracy and quality in work.
- Fluency in French is required.
Full Job Posting
Job Description
- The Project Manager, Regulatory Affairs CMC, is responsible for all Chemical Manufacturing Control submission requirements for assigned product portfolio. The Project Manager is the regulatory contact with local stakeholders and Global Regulatory Affairs and effectively collaborates with Regulatory
Major Activities and Responsibilities
- Coordinating the planning, preparation and submission of global regulatory Chemical Manufacturing Control related submissions, including Marketing Application(s) and post approval changes.
- Ensuring that all submissions are complete, accurate and meet relevant requirements, and that they are prioritized and filed so that there is no regulatory impact on supply.
- Management of Chemical Manufacturing Control 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.
- Interfacing with global Regulatory partners and internal cross functional teams.
- Health Canada requests (i.e. requests for information) are assessed, communicated to management and Global, managed as a priority and within required timelines.
- Filing and maintenance of Clinical Trial Applications submissions (Chemical Manufacturing Control) with Health Canada and compliance with local and global Standard Operating Procedures.
Qualifications
- University Degree, B.Sc. or higher in Chemistry or Health Sciences or equivalent.
- Intermediary experience in regulatory affairs or a related function in a pharmaceutical and/or biotechnology company.
- Working Knowledge of Health Canada regulations, guidance and policies, including a high level understanding of the Health Canada regulatory requirements for Chemistry, Manufacturing and Control submissions.
- Experience with biologics is an asset.
- Excellent time management skills and the ability to work independently with minimal supervision.
- Outstanding interpersonal and communication (written and verbal) skills.
- Proficient with computer and standard software programs, with excellent word processing, presentation and spreadsheet application skills and the ability to learn new computer interface systems.
- Detail oriented, with a high level of accuracy and quality in work.
- Fluency in French is required.
Salary
- The anticipated base salary range for this position is $81,280 $121,920 CAD.
Flexible Work Arrangements
- Hybrid
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