Fladger Associates

 


Regulatory Affairs Doc Coordinator I

Responsibilities:

  • Excellent employment opportunity for a Regulatory Affairs Doc Coordinator-I in the Titusville, NJ area.
  • Review and facilitate signing of documents including Power of Attorney, Letters of Authorization, etc. by internal and external partners, follow by tracking of notarization /legalization and shipment.
  • Track documents throughout the process and resolve issues related to delays or lost requests.
  • Ensure documents are completed and arrive at affiliates before due dates.
  • Provide routine regulatory Support to the Regulatory Leader and Sr. Regulatory Associates in RSI Regional Regulatory Affairs.
  • Significant amount of contact with international markets regional leads to clarify requirements, receipt of information, and critical timelines.
  • Update status of specific projects upon request and debrief on market requests/ needs with project team. Provide weekly progress reports.
  • Track project deliverables in SharePoint (excel spreadsheet) and monitor project status.
  • Responsible for uploading submission documents to SharePoint and ERIS (Electronic Regulatory Information System).
  • Report directly to Director AP &LA, GRA and support global regulatory team.

Experience:

  • To be considered for this Regulatory Affairs Doc Coordinator I job opportunity a B.S. degree in a biologic or chemical discipline.
  • Basic understanding of drug development process and supply chain. 
  • Proficient in Microsoft Word and Excel. 
  • Good written communication skills. 
  • Attention to details and ability to track and organize a large number of submission documents.  
  • Professional demeanor on the phone with partners. 
  • Prior experience in international regulatory affairs preferred. 
     


Send Resume To info@fladgerassociates.net  and include Job Title In Subject Line