Job Details

  • Title: Commercial Regulatory Affairs Submissions Associate
  • Code: RCI-33812-1
  • Location: Lawrenceville New Jersey (NJ) 08648
  • Posted Date: 11/20/2020
  • Duration: 6 Months
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  Job Description

  • The primary responsibilities of an associate in Commercial Regulatory Affairs (CRA) Operations are to perform assigned tasks in electronic routing systems, 2253 submission reviews/system database work and documents and OPDP Accelerated Approval or Advisory Comment binder submissions

Key Responsibilities:

  • Form FDA-2253 Submissions
  • Manage the preparation and finalize the 2253 submission packages (hard copy or electronic format in order to ensure company’s complies with FDA requirements
  • Assist with review of 2253 packages prior to submission to verify compatibility with requirements
  • Update and maintain 2253 Access database and all 2253 related records
  • Provide release notifications to brand partners to ensure promotional material is available for use as specified
  • OPDP Accelerated Approval/Advisory Comment Submissions
  • Review copies of promotional materials and accompanying reference packs (hard copy or electronic format) for Accelerated Approval or Advisory Comment submission packages
  • Ensure electronic routing system and department SharePoint sites have complete copies of submitted material packages, including corresponding cover letters, shipping confirmation, and other supporting documentation as necessary
  • Draft cover letters, ensure up-to-date templates and other binder materials are available and easily accessible for department team members
  • Support exhibit material approval process through verification of materials and ensuring successful process flow between CRA Advisors, Exhibit Services and Print Operations
  • Maintain and archive all records as needed
  • Develop familiarity and adherence to company’s/CRA standard operating procedures and work instructions

Qualifications

  • Ability to learn quickly and adapt to new systems, processes and terminology
  • Data Entry experience
  • Strong organizational skills and attention to detail
  • Experience and willingness to work in a fast paced environment with tight timelines and large deliverables, and to possess strong attention to detail and organizational skills
  • Strong oral and written communication skills and demonstrated ability to communicate ideas clearly, especially with reading comprehension, grammar, spelling and typing
  • Strong working knowledge of Adobe Acrobat, MS Office and electronic routing systems
  • Candidate should be qualified with Bachelor’s Degree (required)