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Job Details


Company: PRA Health Sciences
Location: Various European location
Reference: 2016-36112
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent salary + 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 Global Regulatory Affairs Associate (GRAA) and help realize your career potential.



Location: Serbia, Croatia, Greece, Belgium, Netherlands, Spain, Italy, Portugal, France, Poland, Russia, Romania, Czech, Slovakia, Hungary, Ukraine, Germany, Turkey, Sweden, Norway, Demark, UK 

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 


The Global Regulatory Affairs Associate (GRAA) fulfills the role of Global Regulatory Affairs Lead (GRAL) and is responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met (except in the United States and Canada, where the GRAL does not coordinate central IRB/IEC submissions).  This includes communicating the status of submissions to the Start-Up Lead(s) (SULs) and working with them to mitigate risks to Sponsor deliverables.  In addition, the GRAL is responsible for providing the Sponsor and internal Project Team information on regulations governing the clinical trial at a project level and answering any Sponsor questions surrounding these topics. 

  • Coordination of Central Independent Ethics Committee (Central IEC), Regulatory Agency (RA) and other central or country level authority submissions to ensure contractual timelines are met.
  • Provide the client and the internal team information on regulations and drug considerations at a project level and answer client questions surrounding these.
  • Provide submission strategy to the client along with all requirements and documentation requests to actualize proposed strategy.
  • Preparation of the Core Clinical Trial Application and perform QC on the content of all central submission submission packages to ensure they meet the needs of the trial protocol, sound scientific and therapeutic area principles and any other study requirements.
  • Depending on the scope of the project, create the master IP labels or ensure that Sponsor provided IP labels are in adherence with Annex 13 or applicable regional requirements.  Coordination of country level labeling translation.
  • Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.  
  • Perform role of Global Reviewer in the QC process as appropriate.
  • Act as GRA partner to support the Country Consultant and complete review of Country Fact Sheets to timelines for assigned country(s).
  • Take on responsibility for Subject Matter Expert as designated by GRA Management.  
  • Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs.
  • Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up to date; communicate new information or changes to the Regulatory Intelligence Consultant team.  
  • May work with GRA team members to provide Regulatory consulting services
  • Provide mentoring and training for the GRAA 1 position.
  • Support GRAA 1 with more complex submissions requirements.
  • May be delegated ownership for areas of the Country Knowledge Repository and be responsible for liaising with other operational departments to ensure the database contains accurate Country intelligence.

Desired skills and qualifications:

  • Strong knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
  • Minimum 2 years prior experience preparing RA and Central IEC submissions for Clinical Trial Applications preferred.
  • Strong knowledge of current regional guidelines and regulations is preferred, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
  • Prior experience using computerized information systems required; experience with PC Windows, word processing, and electronic spreadsheets required.
  • Read, write, and speak fluent English; fluent in host country language.
  • Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) required
  • CRO experience preferred.
  • With Director approval and in special circumstances, an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.

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 or call our recruitment department at +44 (0) 1189 518468.
PRA Health Sciences is an Equal Opportunity Employer.  We welcome and encourage diversity in the workplace.

Apply for this job: GLOBAL REGULATORY AFFAIRS ASSOCIATE - Various European locations

Contact Information:

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

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