Regulatory Affairs Associate - Czech Republic

PRA international

Place of work
Czech Republic, Prague
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.

Employee perks, benefits

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 (Bachelor's degree)
University education (Master's degree)

Language skills

Czech - Advanced (C1) and
English - Advanced (C1)

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's Early Development Services (EDS) Group, is one of the business units within PRA that provides comprehensive services such as Phase I and IIa Clinical research, Bioanalytical research and Data Support. PRA'sfacilities are located in the United States, The Netherlands and Central Europe. Over 600 professionals, working from different countries make up PRA's Early Development Services team and work together to get the best results.Patient Pharmacology Services is a group within EDS focusing on early-phase clinical trials in patient populations. With management offices in Germany, and clinical operations in several cities across Central and Eastern Europe (CEE), we now have an opening in one of our units (SK,PL,HU,CZ).

Company address

PRA international
-
- Prague
www.prahs.com

Contact

Contact person: HR Dept.
Tel.: 01189181000
E-mail: send CV
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ID: 2707522   Datum zveřejnění: 31.8.2016