Company: PRA Health Sciences
Location: London- United Kingdom
Closing Date: 11 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 – Global Labelling and help realize your career potential.
REGULATORY AFFAIRS MANAGER- GLOBAL LABELLING
Location : London - 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
Due to a new Strategic Partnership with a large global Pharmaceutical company, PRA are currently looking to hire a new team of experienced Regulatory Affairs Managers with specialism in Global Labelling to join our business (reporting in to the Sponsors' London, UK office)
Within this role you will be the regulatory expert for labeling on the global Regulatory Affairs (RA) Subteam to ensure that regulatory labeling requirements are met for new product submissions.
Additionally, you will be responsible for the development and maintenance of Company Core Data Sheets (CCDS) across multiple therapeutic areas in line with international standards and guidelines.
If you are an experienced Regulatory Affairs Manager who is interested in gaining insight into the pharmaceutical business by working directly with the sponsor and their wider team this could be a great opportunity for you. You will be a fully integrated member of the pharmaceutical company’s research and development team and working frequently at the client site.
Key points about this position:
• You will be fully integrated into one sponsor.
• You will be working directly with this sponsor, using only their SOP’s and will be fully integrated into their IT systems and regulatory affairs teams.
• You will be working in various therapeutic areas across all phases.
• There are office-based and home-based options, offering you the possibility of a better work-life balance.
• You will receive managerial guidance and support at all times from both the sponsor, and PRA Health Sciences management team.
• You will be offered a permanent contract with future opportunities for growth and development within both the sponsor organisation and PRA Health Sciences.
To be considered for this opportunity, you will have a life sciences degree with a minimum of three years’ experience in labeling (or similar skill set) within the pharmaceutical industry. You will have significant knowledge of global standards and regulations related to New Drug Applications, CCDS, and Product Labeling as well as an understanding of scientific principles and regulatory/quality systems relevant to drug development. Demonstrated project management, negotiation, and interpersonal skills are essential, along with the ability to work independently as well as in team-oriented environment.
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.
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