Regulatory Affairs Specialist

ThermoFisher Scientific; Toronto; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading scientific company in Toronto is seeking a project documentation manager to oversee regulatory compliance and document management. This role requires strong expertise in project documentation systems and financial oversight. The ideal candidate has exceptional communication skills and the ability to manage multiple tasks effectively. Join us to contribute to scientific advancements!

Qualifications

• Proven experience in project documentation management, regulatory submissions, and compliance.
• Strong understanding of financial documents and budget management.
• Excellent communication and organizational skills.

Responsibilities

• Upload, track, file, maintain, and review all project-related documents.
• Coordinate submission strategy meetings and communicate submission plans.
• Perform ongoing and final data reconciliation of all systems.

Skills

Project documentation management

Regulatory submissions

Budget management

Communication skills

Organizational skills

Task management

Tools

Clarity

EDMS

eTMF

Job description

Job Description

An outstanding opportunity to craft the future of scientific advancements while ensuring flawless regulatory compliance. With a dedication to collaboration and innovation, you'll help us successfully implement regulatory strategies that drive our ambitious goals forward.

Key Responsibilities

• Document Management: Upload, track, file, maintain, and review all project-related documents according to relevant SOPs.
• Coordinate provision of initial country/site insurance documents per study and country requirements.
• Track and file the master ICF/additional master ICFs and related documents.
• Coordinate tracking and filing of country and site level ICF/additional ICFs and related documents.
• File training documentation in the Electronic Trial Master File (eTMF).
• Perform ongoing and final data reconciliation of all systems used during the study lifecycle.
• Revoke systems access for team members and site staff as necessary.

Financial Review and Management

• Review finance documents and assess scope.
• Review current budget and assess amendment impact.
• Request clarifications and raise risks/issues to Project Lead and Financial Analyst.
• Contribute to Contract Modification (ConMod)/Change Notification Form (CNF) activities.
• Forecast and actualize units in Clarity monthly.

Project Planning and Implementation

• Understand amendment scope, classification, and timelines.
• Confirm participant safety and plan amendment implementation strategy.
• Assess amendment impact for each functional area and vendors.
• Coordinate project and client training compliance.
• Ensure project team members complete training and document appropriately.

Regulatory and Submission Oversight

• Provide oversight of planned and unplanned submissions to Regulatory Authorities and Ethics Committees (EC) for all regions.
• Coordinate submission strategy meetings and communicate submission plans and deadlines.
• Coordinate project-specific communication with Regulatory Authorities.
• Coordinate the development and translation of submission-related documents.
• Prepare the Core Dossier in the applicable Electronic Document Management System (EDMS).

Risk and Issue Management

• Follow the Project Risk Management Process.
• Identify, advance, and resolve project issues through the Project Issue Resolution process (RESOLVE).
• Ensure audit/inspection readiness.

System and Data Management

• Review and ensure accuracy of PPD systems in reporting trial achievements, progress, and risks.
• Raise outdated information requiring updates to the Project Lead.
• Perform final reconciliation of units in Clarity at study closeout.

Qualifications

• Proven experience in project documentation management, regulatory submissions, and compliance.
• Strong understanding of financial documents and budget management.
• Proficient in using project management and documentation systems (e.g., Clarity, EDMS, eTMF).
• Excellent communication and organizational skills.
• Ability to manage multiple tasks and deadlines efficiently.
• Must be legally authorized to work in the United States without sponsorship
• Must be able to pass a comprehensive background check, which includes a drug screening.

Join us in making a difference in the world of science and innovation!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.