- Regulatory Start Up Associate
| - 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.
* Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required.
* 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.
* Follow submission, application to approval.
* 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.
* Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required.
* 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.
| | * Graduate in a clinical, pharmacy or life sciences related field. * At least 1-2 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment.
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