Randstad Regulatory Affairs Associate: EMD Serono in Rockland, Massachusetts
Regulatory Affairs Associate: EMD Serono
Thursday, September 29, 2016
Temp to Perm
Randstad USA Administration
DescriptionSupport and manage the preparation of regulatory documentation for submission to INDs, NDAs/BLAs, SNDA/SBLAs, preclearance of promotional materials under accelerated approval, and maintenance activities including assessment and processing of manufacturing change controls.
MAIN INTERFACES (ranked by order of importance)
Other Global Regulatory functions including Devices, Development, CMC, Labeling and Promotion, Operations, Launch Excellence
Global R&D Development functions
Franchise and Therapeutic Area functions including Marketing, Market Access, Medical Affairs, Safety, Manufacturing, and Quality Assurance functions
Global Project Teams and Regulatory subteams
KEY TASKS & RESPONSIBILITIES
Compliance with Subpart E/H requirements for promotional preclearance submissions
NDA/BLA and IND reporting compliance including Lot Distribution Reports, Periodic Safety Update Reports, Annual Reports
Project Team Member and/or Regulatory Subteam Member for marketed products ,
Technical assessment of submission content against commitments, regulations, and guidance documents
Assure compliance with the reporting requirements for all US marketed products in terms of timeliness and content requirements.
Review and prepare regulatory documents for submission to FDA in compliance with requirements. Documents may include Agency Meeting Requests, Briefing Documents, CMC and Labeling supplements, General Correspondence, Annual Reports and Periodic Safety Reports.
Review of CMC supplements, protocols, and additional regulatory documentation as required
Interface with electronic submission operations group to ensure high quality and complete submissions
Regulatory department tracking databases for planning, scheduling, submissions, and action dates, and overall project coordination and management
Agency liaison for NDA/BLA supplements, maintenance activities, and OPDP submissions, as required
Working hours: 8:30 - 5:00 PM
PROFESSIONAL SKILLS & EXPERIENCE
BA/BS degree in the Life Sciences with 2-5 years industry experience of which at least 2 years regulatory experience and/or RAC
Experience in submission preparation in accordance with ICH, eCTD, and US requirements (e.g., 2253, listings, SPL/XML)
Working knowledge of FDA and international biologics/drug regulations
Experience in project team membership
Experience with regulatory agency interactions and preparation of documents for regulatory agency interactions
Experience with regulatory maintenance activities for authorizations in a local affiliate or head office
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