Location: New York
Closing Date: 22 Dec 16
Salary (£): Negotiable
My client is a leading Pharma/Biotech business with operations globally and with multiple US locations. They are currently looking to secure a Senior Manager Regulatory Labeling to join the organisation here in the US.
The role is wide ranging with a remit to support both pre and post approval labelling activities as well as supporting the compliance with internal SOP’s and external regulations including submissions to external regulatory agencies.
Key responsibilities will include:
Supporting the development, implementation and the maintenance of CCDS and global package inserts. This will include USPI and SmPC to support regulatory submissions.
Supporting the development of systems and processes.
Supporting the review of labelling sections of NDA annual reports
Tracking of CCDS updates
Maintaining up to date with knowledge of regulations, policies and laws of FDA, EMA and other applicable regulatory agencies.
Minimum Bachelors in related field
Minimum of 5 years regulatory experience
Minimum of 2 years regulatory labelling experience
For an opportunity to discuss this unique opportunity in more detail please contact Andrew Carr at A.Carr@sciproglobal.com or 646 810 3847
4th Floor, 150 Leadenhall Street, London
|Tel:||+44(0)203 327 3072|
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