The Regulatory Affairs Associate (RAA) fulfills the role of Local Regulatory Affairs Lead (LRAL) and is responsible for preparing, submitting and following up on initial and amended Regulatory Agency (RA), Central Independent Ethics Committee (IEC), and any other central submissions required in the country(s) they are responsible for, within contracted timelines and budget, in accordance with local regulatory requirements and sound scientific/technical principles, including the creation and modification of documentation required for approval. The RAA is responsible for the provision of information relating to local importation and exportation requirements. Where locally appropriate they may be responsible to carry out all practical steps to ensure that importation and exportation requirements are met for Investigational Product (IP) and any other clinical trial supplies needed for the trial within their country. The RAA 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. Additionally the RAA will ensure that Insurance Certificates, Country Specific Informed Consent forms and any other patient documentation adheres to country requirements.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.