Tbd Global Regulatory Affairs Associate 3

2 weeks ago

Sydney, Australia Icon plc Full time

Primary Responsibilities
- Management of activities associated with obtaining initial, amendment and other central authority approvals for clinical trials i.e. Regulatory Agency (RA), Central Ethics Committee (CEC) and any other central authorities for the assigned country/ countries.
- Management of central/country level ethics or regulatory submissions for clinical trials associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the LRAA is responsible for.
- Ensuring that IP labels are in adherence to country requirements and submitted where applicable for clinical trials.
- Management of the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA and Central CEC as appropriate.
- Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.
- Perform role of Local Reviewer in the QC process as appropriate.
- Providing consultancy to the client on any country specific issues if requested by the Start-Up Lead (SUL), GRAL, Clinical Team Manager (CTM) or Project Manager (PM).
- Supporting the senior level Regulatory staff/Country Consultant in the maintenance of the accurate, up to date Country Knowledge Repository.
- Attending internal and external project team meetings as determined by the GRAL, SUL, CTM or PM.
- If applicable for the Country, submit expeditable safety reports to RAs and central ethics committees in accordance with relevant legislation and the project-specific contractual agreement.
- Any other duties deemed necessary to secure the success of PRA’s business.
- Support Business Development opportunities by providing regulatory input for clinical trials on assigned RFPs, RFIs and BDMs.
- Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up to date; communicate new information or changes to the Regulatory Intelligence Consultant team for clinical trials.
- May work with GRA team members to provide Regulatory consulting services.
- May support, prepare and review GMP and product (drug products, medical devices, cosmetics, food, supplement) submissions for product registration and maintenance to Regulatory Agencies with appropriate oversight, supports labeling (leaflet, primary and secondary packaging) and promotional material activities based on relevant regulations for clinical trials and updates regulatory systems accordingly.

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