Regulatory Affairs Doc Coordinator I
- 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.
- 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 firstname.lastname@example.org and include Job Title In Subject Line