Are you a Regulatory Affairs professional looking to work independently and take ownership of the writing of CMC sections of DMF, BLA, and NDA submissions? Have you supported full product development activities from pre-clinical/clinical to FDA submissions? Are you interested in helping a company expand their client base in new countries? Do you have experience independently writing CMC sections of global regulatory submissions? This position could be for you!
If you're interested in a Lead Regulatory Affairs Specialist position with a well established pharmaceutical company in Madison, Wisconsin, apply here for more details!
Key Responsibilities: Responsible for reviewing all data scrapes for accuracy, standardizing toplines, and pulling product images using independent internet research or working with suppliers Work cross functionally to ensure all item data is accurate, correctly ...
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