RA Coordinator

Highly Competitive
  1. Permanent
  2. Officer /Associate
  3. United States
Irvine, California
Posting date: 07 Mar 2019

ProClinical is advertising a vacancy for an RA Coordinator with one of the world's largest workforce management solutions companies in the world. This exciting and prestigious organization is seeking applicants to join their team in California.

The RA Coordinator will support the Regulatory Affairs Department in activities associated with preparing and submitting documentation to regulatory agencies, including coordinating electronic and paper-based submission production and shipments, maintaining regulatory files, and tracking submissions and payments.

Job Responsibilities:

  • Responsible for ensuring personal compliance with all Federal, State, local, and company regulations, policies, and procedures for Health, Safety and, Environmental compliance.
  • Coordinating submission and application preparations, including inventory of supplies.
  • Creating regulatory submission e-copies and file paper copies.
  • Preparing and coordinating submission shipments.
  • Maintaining regulatory submission files.
  • Providing documentation to international affiliates for registration of products in their country.
  • Preparing Power of Attorney and other sensitive documents required by international affiliates for registration, to be signed by Manager/Director level or above.
  • Working cross functionally with Manufacturing, R&D, and other areas to obtain copies of documents for product registration.
  • Coordinating with internal and external sources to accomplish activities.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Preparing and entering Regulatory Change Orders, researching and releasing products for shipments on Regulatory hold status as appropriate.
  • Providing administrative support to the Regulatory department.
  • Tracking accruals, obtaining purchase orders or checks for FDA user fees, notifying body dossier assessment fees, and acting as ARIBA super user for Regulatory Department.
  • Other duties as assigned.

Skills and Requirements:

  • Requires minimum of a bachelor's degree.
  • Minimum 1 year of experience in Regulatory Affairs or related healthcare field.
  • 2-3 years' experience in team support or administrative assistant capacity, preferably in a medical device, biotech, pharmaceutical company, or hospital setting.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Samantha Reader at +267 983 0134, or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.