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Job Details

REGULATORY AFFAIRS ASSOCIATE - Czech Republic

Company: PRA Health Sciences
Location: Czech Republic
Reference: MH-2017-43100
Closing Date: 29 Nov 17
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary and Benefits

Job Summary:

An outstanding opportunity to join one of the world’s leading contract research organisations and be part of a dynamic and growing international company. Join PRA Health Sciences as a Regulatory Affairs Associate and help realize your career potential

Requirements:

REGULATORY AFFAIRS ASSOCIATE

Location: Czech Republic

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

For more information please see our website: www.prahs.com

Responsibilities:

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.

Desired skills and qualifications:

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.

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.

If you have any questions please email recruiteruk@prahs.com or call our recruitment department at +44 (0) 1189 213652 

PRA Health Sciences is an Equal Opportunity Employer.  We welcome and encourage diversity in the workplace.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

Apply for this job: REGULATORY AFFAIRS ASSOCIATE  - Czech Republic

Contact Information:

Address:  Head Office
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
England
Tel:  +44 (118) 918 1000
Fax:  +44 (118) 918 1001
Website:  Visit Our Web Site

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