Ľutujeme, spoločnosť ponúkajúca danú pracovnú pozíciu ukončila zverejnenie ponuky na stránke.
Ďakujeme za porozumenie.
Zobraziť podobné ponuky
Ďakujeme za porozumenie.
Zobraziť podobné ponuky
Local Regulatory Affairs Associate
PRA international
Place of work
Prague
Prague
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
Description
The Local Regulatory Affairs Associate (LRAA) 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 LRAA 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 LRAA 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 LRAA will ensure that Insurance Certificates, Country Specific Informed Consent forms and any other patient documentation adheres to country requirements.
To be considered for the Local 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 pharma or CRO. Experience of Regulatory submissions is required.
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.
The Local Regulatory Affairs Associate (LRAA) 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 LRAA 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 LRAA 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 LRAA will ensure that Insurance Certificates, Country Specific Informed Consent forms and any other patient documentation adheres to country requirements.
To be considered for the Local 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 pharma or CRO. Experience of Regulatory submissions is required.
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.
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Advertiser
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: 2043569
Dátum zverejnenia: 11.3.2015
2015-03-11
lokalita: Prague Pozícia: Regulatory Affairs Manager Spoločnosť: PRA international