Chef de projets, Affaires réglementaires (CMC) / Project Manager, Regulatory Affairs (CMC)
About The Position
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. 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 Clinical Units. This requires collaborative interaction with component providers and other Regulatory Affairs Project Managers to ensure quality, right first-time output, and timeliness. The Project Manager may also undertake other additional activities including projects and leadership of team initiatives. The position reports to the Associate Director, Chemical Manufacturing Control Unit.
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 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
Nice To Haves
- Experience with biologics is an asset
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
Benefits
- discretionary short-term-incentive plan
- contemporary rewards and benefit programs
- medical plans
- retirement programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
