Regulatory Affairs Associate - Czech Republic

PRA international

Place of work
Prague
Contract type
full-time

Information about the position

Job description, responsibilities and duties

Due to our constant expansion PRA is seeking a Regulatory Affairs Associate (RAA) to join our team based in Prague, Czech Republic.

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

For the successful candidates we offer a competitive salary together with the comprehensive range of benefits and the opportunity to work in a supportive environment where we encourage and nurture professional development and growth.

Information about the selection process

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

English - Advanced (C1) or
Czech - 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 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

Contact

Contact person: HR Dept.
Tel.: 01189181000
E-mail: send CV
Send CV to the company
ID: 2833138   Datum zveřejnění: 30.11.2016