Regulatory Affairs Associate - Czech Republic

PRA international

Place of work
Prague, Czech Republic
Contract type
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.

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.

Requirements for the employee

Candidates with education suit the position

University education (Master's degree)
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.

Company address

PRA international
-
- Prague
www.prahs.com
ID: 2736164   Datum zveřejnění: 26.9.2016