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Job Description
2 openings - Sr. Regulatory Affairs Associate/Manager & Regulatory Documents Specialist
Sr. Regulatory Affairs Associate/Manager:
Potential candidate needs to have direct experience investigating, preparing, and submitting NDAs. In addition, it would be very helpful that this experience involve either topical or internal products NDA. Reports into head of RAQA and Manager of RA. The person needs to have at least a bachelor’s degree in a science or technical field.
Description of Sr. Regulatory Affairs Associate/Manager -
The person will be coming in and needs to have knee deep experience within NDA filing in Regulatory Affairs. They work with an outsourced company (CRO). Right now everything is manual and paper but they can go to electronic, etc. Just depends on what they work out (the person we hire in). They need someone not at a director level, etc but someone who can get their hands dirty. “I want someone who has been in the trench of filing an NDA before. We have multiple programs running right now. This person will take one of the programs and run with it, work with our sourcing partner, etc." They will need to do data investigation, prepare and submit the NDA.
Regulatory Documents Specialist:
This person will need to look at database- QA of database. They have an Excel system- recently had lots scanned. Look at thinks on excel spreadsheet make sure have off scanned. Need someone familiar with Regulatory documents (so when looking at document- they know what to look for). Look at candidates with 2
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