Regulatory Affairs Coordinator
hace 7 días
We are seeking a highly organized and detail-oriented Regulatory Affairs Coordinator to join our team at Worldwide Clinical Trials, LLC. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the smooth operation of our regulatory processes.
Key Responsibilities- Coordinate and manage the compilation of regulatory submissions, including protocols, synopsis, ICFs, and labels, for various regions, including EU, CIS, Asia Pacific, and Latin America.
- 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 payments 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 contract 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 the generation of slides.
- Provide relevant administrative training and support to junior staff.
- Manage third-party vendors, such as printing, courier, and translation service providers.
- Provide general administrative assistance for the smooth running of the department, including organizing meetings and recording minutes, managing diaries, and assisting with process improvement initiatives.
- May administratively support therapeutic area-specific training activities in coordination with the SAR department Training Lead, if needed, or for professional self-development, if desired.
- 2 years of office/business experience in a supporting role.
- Preferable CRO/pharmaceutical industry experience.
- Bachelor's degree or equivalent preferred.
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Regulatory Affairs Coordinator
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