Regulatory Start Up Associate

4 days ago

บางกอกใหญ กรงเทพมหานคร, Thailand Novotech Asia Full time

Core Responsibilities:

- Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects.
- Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries.
- Work within the scope of the Regulatory Start-Up plan or other applicable project plan, relevant SOPs, and ICH-GCP.
- Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
- Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals
- May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities
- Ensure submission packages are accurate and complete per local requirements
- Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe.
- May serve as a point of contact for Regulatory Authorities, Ethics Committees/Review Boards and other local authorities
- Prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements
- Escalate any issue to the RSM and/or PM and provides rationale for submission/approval delays, and contingency plan to mitigate impact
- Perform country and site Informed Consent Form (ICF) customisation in line with local requirements
- Initiate translation of submission documents as applicable and review translated documents before submission
- Review and approve proposed packaging and labelling for clinical trial material
- Register project onto an official clinical trial registry as agreed to with Client and update status as required
- Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents
- Serve as an independent essential document reviewer and performs 2nd review of Activation Forms for IP release if required.
- Where applicable, may act as a Country Lead for projects with no RSM.

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