Regulatory Affairs Coordinator, International Support

Location
Bridgewater NJ
Posted
Apr 13, 2021
Required Education
Bachelors Degree
Position Type
Contract

Responsibilities

  • Provide Information and Regulatory Support to International RA team members for Product Registrations, Renewals, Launches, etc. oo provide support and needed information to all global regions on all US products across the client and subsidiaries’ product portfolio so that regions can file products with the needed documentation and information for their submissions.  
  • Responsible for providing Regulatory Affairs support to International RA teams for product registrations, renewals to global markets for all US approved/cleared products including pharmaceuticals, medical devices, nutritionals and skin care products.
  • The incumbent will provide support for all requested documents (certificates/letters), search and retrieve product labeling & all needed support documentation.

With the oversight of Regulatory leadership, the incumbent will prepare and obtain: 

  • Letter of Authorizations/Letter of Declaration/Power of Attorney Letters
  • Certificate of Free Sale from State of NJ/ CPP from Federal Agency ( FDA)
  • Notarized, Legalized, or Apostilled Regulatory Documents

Will also be working on:

  • Technical Inquiries and coordination (including Manufacturing, process, raw materials, technical files)- Search and retrieve documents from RA system and tools and provide links to the international requestors (Sharepoint, Clin-ops, Liquent /Insight viewer) where information can be found. Work with other International Support groups (Operations, QA, etc.) to provide assistance to regions.
  • US Regulatory Support for all client regions on US cleared/approved products
  • Internal R&D and Business functional groups to support R&D Development projects as well as expand already approved products throughout client regions.
  • Regional functional groups (mainly Regulatory)
  • External contract manufacturing organizations (CMO) and partners

Qualifications

  • BS in Biological Sciences preferred
  • 5 or more years of Experience in Regulatory Affairs (preferably on Global programs)