Regulatory Affairs Specialist
Regulatory Affairs Specialist
Posted on :
25-09-2025
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1 Vacancy
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
An outstanding opportunity to craft the future of scientific advancements while ensuring flawless regulatory compliance. With a dedication to collaboration and innovation youll 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 withoutsponsorship
- Must be able to pass a comprehensive background check whichincludes a drug screening.
Join us in making a difference in the world of science and innovation!
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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