Regulatory Affairs Specialist
Edison-New Brunswick Metro Area, NJ
- Bachelor's or Masters degree with Experience in GDUFA (Generic Drug User Fee Amendments) pharmaceutical/biopharmaceutical industry or related industry/cGMP environment supporting Regulatory Affairs.
Good understanding of scope and requirements for Module 3 content as well as drug and drug substance manufacturing change controls to be able to translate the knowledge into review and preparation of documents needed for submission.
The individual must understand electronic publishing systems to be able to engage in the review of Drug Master File submission documents and communicate outstanding requirements with the sites to ensure satisfaction of FDA electronic eDMF requirements and internal processes.
Be able to take on other projects as necessary; electronic drug listing, letters of authorization etc.
Well-developed communication skills, both verbal and written and project management skills.
Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.