The Regulatory Affairs Associate - Logistics (RAAL) is responsible for ensuring that all importation and exportation requirements are met for Investigational Product (IP) and any other clinical trial supplies needed for the trial within their country. The RAAL is also responsible for providing review of the translation into the local language of clinical trial supply labeling to ensure it meets local regulatory requirements.&
- Management of activities associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) including:
- liaison with applicable parties (i.e. drug depots, customs agents, courier companies etc) to ensure IP and clinical trial supplies are available in country to meet the needs of the trial and that import/export requirements are met;
- tasks required to set up a local depot as required, including budget agreement, liaison with PRA legal regarding contract negotiation etc;
- management and tracking of shipments;
- organisation of local purchase of study related materials including drugs, supplemental materials, equipment etc;
- preparation or review of required documentation including export documents, import/export license submission packages pro forma invoice templates etc;
- organisation of relabeling and destruction processes at Depot and ensuring that all study materials are returned to Sponsor at study end.
- management of vendor invoices (verification, negotiation with Project Manager (PM), Project Analyst (PZ) and PRA accounts department)
- Determine country level/central importation/exportation requirements for the country(s); advise project team of the requirements of logistics procedures in the country(s) and ensure that documentation and procedures meet the requirements of the country(s) and the project.
- Ensure that IP labels are in adherence to country requirements and to study related documents (e.g. Certificate of Analysis, Letter of Authorisation, protocol etc.).
- Tracking and reporting of all logistics related activities in PRA systems.
- Support the Senior level Regulatory staff/Country Consultant in the maintenance of the accurate, up to date Country Intelligence.
- Attend internal and external project team meetings as determined by the GRAL/Start-Up Lead (SUL)/Clinical Trial Manager (CTM) or Project Manager (PM)
- Any other duties deemed necessary to secure the success of PRA’s business.
- Appropriate escalation of issues.
- Act as local reviewer to QC documentation prepared for submission.
- Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs.
- Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that tools such as the Country Intelligence isup to date; communicate new information or changes to the Regulatory Intelligence team. &
- Provide mentoring and training for the RAAL 1 position.
- Support RAAL 1 with more complex importation/exportation requirements.
- May serve as Country Consultant.
- May liaise with team/other department members to validate Country Intelligence before liaising with the appropriate GRA team member to ensure that the information is disseminated appropriately.
- g knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development. Minim
- um 2 years prior experience in CRO or pharma preferred. Stron
- g knowledge of current regional guidelines and regulations is preferred, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region. Prior
- experience using computerized information systems required; experience with PC Windows, word processing, and electronic spreadsheets required. Read,
- write, and speak intermediate English; fluent in host country language
- Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) required
- Experience in logistics industry is preferred.