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
...02 West Armitage Ave, Chicago, IL 60614 . The Hotel Chocolat Sales Associate is responsible for ensuring that customers are welcomed... ...sure that our stores, inclusive of all elements of Retail, Food & Beverage, are well presented according to our Retail Excellence...
...your development. Whether youre working in our four global Home Offices, Distribution Centers or Retail StoresTJ Maxx, Marshalls, Homegoods, Homesense, Sierra, Winners, and TK Maxx, youll find abundant opportunities to learn, thrive, and make an impact. Come join our...
...wellsite proppant storage capabilities. We provide our products and services primarily to oil and natural gas exploration and production companies and oilfield service companies. To learn more about our exciting organization and/or to apply go to smartsand.com.
...Job Description Jackson PharmacyPros is seeking a travel Pharmacy Technician for a travel job in Dublin, Ohio. Job Description & Requirements ~ Specialty: Pharmacy Technician ~ Discipline: Allied Health Professional ~ Start Date: 08/02/2025~ Duration:...
...oriented Senior QA Engineer with expertise in mobile application testing to join our dynamic team. In this role, you will lead quality... ...based on product requirements and technical specifications. Perform functional, regression, UI/UX, performance, and compatibility testing...