Senior Manager Regulatory Labeling
|Job Title:||Senior Manager Regulatory Labeling|
|Location:||New York, New York|
|Contact Name:||Andrew Carr|
|Job Published:||December 05, 2016 21:41|
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
Get similar jobs like these by email
By submitting your details you agree to our T&C's
Senior Manager Regulatory Affairs CMC (m/w/d) | Nürnberg
€80000 - €95000 per annum
Regulatory Affairs Manager
Regulatory Affairs Project Manager
San Francisco Bay Area
Senior Strategist Clinical Regulatory Affairs (f/m/d)
€90000 - €100000 per annum + + negotiable
Regulatory Affairs Manager - Neuzulassung (m/w/d)
€60000 - €70000 per annum + negotiable