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Megértését köszönjük.
Mutasd a hasonló álláshirdetéseket
Megértését köszönjük.
Mutasd a hasonló álláshirdetéseket
Regulatory Affairs Associate - Czech Republic
PRA international
Place of work
Prague, Czech Republic
Prague, Czech Republic
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
As a Regulatory Affairs Associate (RAA) 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 Czech Republic. 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.
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.
Information about the selection process
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.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Postgraduate (Doctorate)
Postgraduate (Doctorate)
Educational Specialization
Pharmaceutical Sector
Language skills
English - Intermediate (B1)
Personality requirements and skills
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 Czech and English is essential.
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Brief description of the company
PRA is a top five CRO that has 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.
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.
ID: 2736164
Megjelentetés dátuma: 26.9.2016
2016-09-26
Régió: Prague Pozíció: Regulatory Affairs Manager, Regulatory Affairs Specialist Cég: PRA international