We are seeking a detail focused individual to join our clients Regulatory Affairs team. This person will be responsible for submitting new ANDA applications, Supplements, and drug listings.
Responsibilities will include thoroughly reviewing documentation for accuracy and completeness. Working cross-functionally with multiple departments to coordinate and assemble a complete and accurate Annual Report on-time according to the schedule. Assembling other regulatory submissions i.e.: ANDA applications, etc.
The chosen individual will need to be highly organized, have the ability to locate and interpret current government regulations and guidances. Excellent PM skills, ability to work in a multi-disciplined environment. BS in Science --preferrably Chemistry or Pharmacy with a minimum of 1-2 years pharmaceutical experience with ANDAs.
