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:
PRA Health Sciences is experiencing ongoing Global expansion, our business is thriving and we are looking for enthusiastic Regulatory Affairs professionals to grow with our business.
The Global Regulatory Affairs Lead (GRAL) is responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met. This includes communicating the status of submissions to the Start-Up Lead(s) (SULs) and working with them to mitigate risks to Sponsor deliverables.
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.
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 packages. Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and Bid Defency Meetings (BDMs)
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.
Due to company growth the Global Regulatory Affairs Associate could be based in other European locations including Spain, Italy, France, UK, Portugal, Hungary, Poland, Russia, Switzerland, Romania, Bulgaria, Belgium, Netherlands and others, please get in touch to see if your location would be a possibility
Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
Prior experience preparing RA and Central IEC submissions for Clinical Trial Applications preferred.
Knowledge or awareness 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
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 (0) .
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.