Randstad Regulatory Affairs Associate: EMD Serono in Rockland, Massachusetts

Regulatory Affairs Associate: EMD Serono


Rockland, MA

Date Posted:

Thursday, September 29, 2016

Job Type:

Temp to Perm

Reference #:






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


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



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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