Company: PRA Health Sciences
Location: United Kingdom
Closing Date: 15 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary and 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 a Manager Global Labelling and help realize your career potential.
MANAGER GLOBAL LABELLING
Location: United Kingdom
PRA Health Sciences is excited to offer new opportunities within our new partnership agreement with a global pharmaceutical company. The innovative partnership provides an operating model that combines operational expertise with PRA's wide range of global capabilities. This flexible approach will facilitate the development of new medicines by focusing resources, teams and activities where needed, an important requirement for an industry-leading, highly agile R&D organisation focused on meeting patient needs.
For more information please see our website: www.prahs.com
We currently have openings in the Regulatory Affairs team and are looking for a Manager, Global Labeling.
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.
Desired skills and qualifications:
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 email@example.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.
500 South Oak Way
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