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Job Details

REGULATORY AFFAIRS ASSOCIATE (RAA) - Poland

Company: PRA Health Sciences
Location: Warsaw - Poland
Reference: 2016-35993
Closing Date: 15 Dec 16
Type: Permanent
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 (RAA) and help realize your career potential.

Requirements:

REGULATORY AFFAIRS ASSOCIATE (RAA)

Location: Warsaw, Poland

As a top five CRO, we have 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. 

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

We are currently recruiting for a Regulatory Administrator to join our Global Regulatory Affairs department based in Warsaw. This varied administrative role may involve but not will be limited to the following tasks:

The Regulatory Affairs Associate (RAA) 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 RAA 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 RAA 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 RAA will ensure that Insurance Certificates, Country Specific Informed Consent forms and any other patient documentation adheres to country requirements.

To be considered for the 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 desirable but not essential. The role may be also be open to the right candidate with a masters or other post-graduate qualification who is looking for an entry level role into regulatory affairs.

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.

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 5185 63. 

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

Apply for this job: REGULATORY AFFAIRS ASSOCIATE (RAA) - Poland

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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