Regulatory Affairs Specialist
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.
- 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
- Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.Some experience preparing RA and Central IEC submissions for Clinical Trial Applications preferred.
- Knowledge or awareness 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 fluent English; fluent in host country language
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) required
- With Director approval and in special circumstances, an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
- Management of activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee(IEC) and any other central authorities for the assigned country/ countries.
- Management of central/country level submissions 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.
- 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 IEC 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 specifics 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 IECs 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 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.
- May work with GRA team members to provide Regulatory consulting services
JOB ID: 65345
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Job posted: 2020-07-14