Regulatory Affairs Specialist

ID# DCPA26594

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

The Regulatory Affairs Associate/Publisher is responsible for managing the compilation of US regulatory agency submissions in support of new product development activities as well as marketed product maintenance activities.Responsibilities will also includeinteraction with the regulatory liaisons with specific product responsibilities and document contributors.

Responsibilities include:

  • Compilation of electronic- or paper-based submissions necessary to meet regulatory requirements using available electronic publishing tools
  • Working with submission teams and regulatory project leads to prioritize submission related activities to ensure submissions are published and dispatched within established timelines
  • Providing support for data entry, maintenance and retrieval of documents/information from document management systems; providing expertise to submission teams regarding electronic (eCTD) submissions and submission technical issues
  • Ensuring that regulatory computer systems are used in accordance with standard operating procedures and work instructions
  • Contributing to the creation or update of standard operating procedures

Position Details:

Consumer Product

Clinical Research

Start Date: 
9-3-2013
End Date: 
8-31-2014

FORT WASHINGTON, PA

CON_W2

37.5

DCPA26594

No

No