Description
Regulatory AffairsReview 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.
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 Senior Director AP &LA, GRA and support global regulatory team
Specific job requirements
1. Basic understanding of drug development process and supply chain.
2. Proficient in Microsoft Word and Excel.
3. Good written communication skills.
4. Attention to details and ability to track and organize a large number of submission documents.
5. Professional demeanor on the phone with partners.
6. Prior experience in international regulatory affairs preferred.
7. B.S. degree in a biologic or chemical discipline
To find out more about Real Staffing please visit www.realstaffing.com