Purpose
This position will support the regulatory reviews in the MLR process. The position will support regulatory intelligence including monitoring regulatory news and updates and summarizing and circulating the same. The position will also support regulatory compilation work for PreIND, IND, NDA or ANDA filings as well as REMS activities as needed.
Position / Job Title - Officer
Department - Regulatory Affairs
Reporting To - Manager/Sr. Manager - RA
Location- New Jersey
Years of Experience- 2-5 years
Job Responsibilities / Deliverables
• Support the regulatory assessments of MLR assets and filings.
• Support on REMS activities and filings.
• Support regulatory compilations for PreIND, IND, NDA and ANDA filings.
• Support with literature searching
• Support on petition filings.
• Tracking and monitoring petitions and preparing monthly updates
• Support regulatory intelligence work involving monitoring updates and news and
summarizing and compiling them.
Qualifications & Pre-Requisites
• B.S/M.S in Pharmaceutical Sciences
• Knowledge about Pharmaceutical Product Development.
• Excellent communication, planning, analytical and interpersonal skills