Queens, NY: ANDA Regulatory Submission Specialist (225886)
Life Sciences & Technology
Location: Queens, NY Area
Duration: 6-12 months
A Black Diamond client is looking for a Sr. Regulatory Affairs specialist who can help with an ANDA submission with no guidance. This individual will be compiling the data to meet current standards helping with the ANDA from start to finish, eCTD publishing, with an emphasis on CMC. This individual will be tasked with reviewing and verifying tables, writing summary sheets, and collecting all the data from different groups (R&D, Quality etc). The ideal candidate will have a strong personality and be able to gather and secure the data from other teams.
BS is a must in science field, advanced degree is a plus