Regulatory Affairs Associate - (Rockland, MA)

Randstad is hiring a Regulatory Affairs Associate to work with our client, a biopharm company located in Rockland, MA. Start Date: 01/28/19 -07/26/19 (possible to extend and/or convert) Duration: six months Client Factoid: 1 of Boston's top 100 places to work, this company is currently researching a cure for MS and may just be the ones to find it. Job summary: Senior Manager Global Regulatory Affairs US Lifecycle Management & Compliance PURPOSE OF THE ROLE To support and manage the preparation of regulatory documentation for submission to FDA for assigned therapeutic areas/products and serve as a Regulatory Agency liaison for INDs, NDAs/BLAs, SNDA/SBLAs and maintenance activities including assessment and processing of manufacturing change controls for marketed products in Oncology and serve as a back-up for other activities (e.g., Neurology/Immunology, Reproductive Health, and Endocrinology) Responsibilities: