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Regulatory Affairs Coordinator
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We are seeking a highly organized and detail-oriented Regulatory Affairs Coordinator to join our team at Worldwide Clinical Trials. In this role, you will be responsible for coordinating and managing regulatory submissions, site contracts, and site documents across various regions. If you have a strong background in office administration and a passion for regulatory affairs, we encourage you to apply.
Key Responsibilities- Coordinate and manage regulatory submissions, site contracts, and site documents across EU, CIS, Asia Pacific, and Latin America regions
- Assist with the coordination of translation of regulatory correspondence and submission documents
- Pack and dispatch regulatory submissions, site contracts, and site documents, and follow up for delivery confirmation
- Perform administrative QC of regulatory submissions, site documents, and site contracts to ensure correct completeness and formatting
- Liaise with Finance to request fee payment to Regulatory Authorities
- Closely monitor the assigned Therapeutic mailbox and triage requests to the correct team members for prompt action
- Contribute to the development and maintenance of Country Intelligence Pages
- Coordinate Contracts signatures by Worldwide authorized personnel, where applicable
- Ensure department-specific study files are submitted to Central Records and are consistently audit-ready
- Manage tracking of original site contracts delivery to Worldwide Central Archive and/or Sponsor
- Prepare and submit hardcopies or electronic copies of site essential documents for storage at Central Records
- Support Business Development activities by archiving emails and assisting with generation of slides
- Provide relevant administrative training and support to junior staff
- Provide admin support to Country Intelligence pages and database, Feasibility activities
- Manage third-party vendors such as printing, courier, and translation service providers
- Provide general administrative assistance for the smooth running of the department
- 2 years of office/business experience in a supporting role
- Preferable CRO/pharmaceutical industry experience
- Bachelor's degree or equivalent preferred
We offer a dynamic and supportive work environment, and we are committed to helping our employees grow and develop in their careers. If you are a motivated and detail-oriented individual who is passionate about regulatory affairs, we encourage you to apply for this exciting opportunity.
