Company: PRA Health Sciences
Location: United Kingdom
Closing Date: 25 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent salary + benefits
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 Regulatory Affairs Manager - Established Products and help realize your career potential.
REGULATORY AFFAIRS MANAGER - ESTABLISHED PRODUCTS
Location : United Kingdom
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 currently have openings in the Regulatory Affairs team and are looking for an experienced Manager of Regulatory Affairs, Global Established Products.
Within this role, you will be responsible for handling global Regulatory Affairs maintenance work on licensed product(s) in close collaboration with regulatory counterparts in affiliate companies. You will plan, manage and execute regulatory activities on licensed product(s) such as submission of variations, renewals, line extensions, responses to Authority requests, Marketing Authorisation Applications in further countries. You will also serve as the Regulatory Affairs representative in the Safety Management Team and other internal teams.
To be considered for this opportunity, you will have a life sciences degree with experience in global Regulatory Affairs maintenance work. Experience in interactions with European Regulatory Authorities in relation to all aspects of regulatory activities is essential, along with proven European regulatory submissions capabilities, in particular in post authorisation. You will be pro-active and self-driven with excellent organisations skills and a positive attitude.
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 firstname.lastname@example.org 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.
500 South Oak Way
|Tel:||+44 (118) 918 1000|
|Fax:||+44 (118) 918 1001|
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