Previous Job
Previous
Excellent job opportunity of Regulatory Affairs Specialist III, Bridgewater, NJ, 7610047
Ref No.: 17-87692
Location: Bridgewater, New Jersey
Start Date / End Date: 12/04/2017 to 12/31/2018
Job Title:  Regulatory Affairs Specialist III
Duration: 13 months
Location: Bridgewater, NJ
Client : A Big Pharmaceutical Client

 
Duties:
  • Experience in GDUFA pharmaceutical/biopharmaceutical industry or related industry/cGMP environment.
  • 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 client 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.
Skills:
Needs a candidate with technical and publishing skills.
  • FDA
  • Project management
  • Publishing
  • Regulatory affairs
  • Translate
 Education
Master’s Degree

Interested candidates can share thier most updated resume at ridhi.thapa@artechinfo.com or reach out to me at 973-295-4583