Click here to login or register
Reference # : 17-00709 Title : Regulatory Associate - US
Location : King of Prussia, PA
Experience Level : Start Date / End Date : 09/18/2017 / 09/17/2018  
Description
Functional Title: CMC Regulatory Manager

The scope of the work is to partner with CMC Regulatory Affairs personnel by reviewing historical CMC registered files (BLAs/supplements/amendments) and authoring/compiling compliant CTD formatted documents within project timelines and with limited oversight.

Requirements:
? Minimum of a bachelors degree in a scientific discipline plus 3 or more years of CMC experience with for FDA-regulated biologics (small molecule experience will also be considered).
? Understanding of US regulations and regulatory expectations for biologics.
? Understanding of biologics manufacturing and analytical methods.
? Background in a functional discipline related to biologics CMC a plus (cell banking, upstream or downstream operations, secondary manufacturing, validation, analytical testing, etc)
? Experience in the critical review of submissions for content, quality and compliance
? Experience with technical writing of CMC documents
? Experience with documentum and the aptitude to learn various IT systems as they relate to training, document creation, formatting, publishing activities, etc.

In additional the candidate must be fluent in English, detail oriented. Must be flexible in terms of changing priorities and deadlines, as well as possess the interpersonal skill to work in a matrix team environment.