Regulatory Affairs Specialist

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• Raise outdated information requiring updates to the Project Lead.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 withoutsponsorship
• Must be able to pass a comprehensive background check whichincludes a drug screening.

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