Regulatory Affairs Specialist

Regulatory Affairs Specialist:

W/ minimal supvn assists w/ the prep'n of high-qlty regulatory submissions to the Food and Drug Administration (FDA) as reqd, w/in co. timelines & in accordance w/ regulatory guidelines & applicable federal laws. This incl, but is not limited, to New Drug Application (NDA), Investigational New Drug Application (IND), Biologics License Applications (BLA), Post-Approval Supplements, Annual Reports (AR), & Periodic Adverse Drug Experience Reports (PADERs). Reqmts: Must have at least a Bachelor's deg in Pharmacy Admin or Chemistry or Pharmaceutical Mfg, or rltd field. Must have at least 60 mos of exp in the advertised position or in a rltd position. Salary: $117K - $120K/annum. Medical/Dental/Vision/Life offd. Hours: 40 hrs/wk, 8:30am - 5:30pm. Loc: Piscataway, NJ. Send resumes to: Amneal Pharmaceuticals LLC, 1 New England Ave, Piscataway, NJ 08854. Attn: HR Ref: # 12542.