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REGULATORY AFFAIRS ASSOCIATE - Romania Nr ref.: /JOBS.pl REGULATORY AFFAIRS ASSOCIATE Location: Bucharest, Romania As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs. At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace. At PRA, borders do not create boundaries. PRA's success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages - yet operate in unison as one worldwide PRA community. For more information please see our website: Responsabilities: As a Regulatory Affairs Associate you are responsible for preparing, submitting and following up on initial and amended Ministry of Health (MoH), Central Independent Ethics Committee (IEC), and other central submissions required in Romania. This includes the creation and modification of documentation required for approval. Furthermore, you will ensure that all importation and exportation requirements are met for the Investigational Product and any other clinical trial supplies. You will review the translations of clinical trial supply labeling to ensure it meets local regulatory requirements. Additionally, you will make sure that Insurance Certificates, Country Specific Informed Consent forms and any other patient documentation adheres to country requirements. Desired skills and qualifications: To be considered for the Regulatory Affairs Associate position you must have a BA/BSc (or equivalent) in a related science field along with experience working within clinical trials regulatory affairs within either a pharma or CRO. Experience of Regulatory submissions is required. Fluency in English and Romanian is also essential. Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale. If you have any questions please email or call our recruitment department at (0) . PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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