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Regulatory Affairs Associate

Company description:

PRA As a leading CRO, PRA is transforming clinical trials through our people, innovation and transparency. We combine therapeutic and operational expertise with local knowledge to serve clients across all phases of drug development. Our successful history of helping to bring new drugs to market demonstrates our successful approach to clinical research. PRA supports our global reach through flexible and reliable service delivery. Thanks to our advanced technological tools and finely tuned systems, we achieve seamless delivery and operational transparency throughout our organization. PRA's dynamic services and forward-thinking approach are making a difference to healthcare patients worldwide.

Job description:

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 The Regulatory Affairs Associate (RAA) is responsible for preparing, submitting and following up on initial and amended Ministry of Health (MoH), Central Independent Ethics Committee (IEC), and any other central submissions required in the country(s) you will be 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 ensuring that all importation and exportation requirements are met for Investigational Product 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.

Required profile:

To be considered for the Regulatory Affairs Associate position you must have a BA/BSc (or equivalent) in a related science field along with some experience working within regulatory affairs within either a Pharmaceutical company or CRO. 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. Will pay a salary fully commensurate both with the significance of this appointment and with the required calibre of the successful candidate. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

What we offer:

Competitive Salary & benefits

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