Senior Specialist - RSPM - Temp
Responsible for supporting document management of Clinical Trial Applications (CTA) and related health authority submissions through collaborations with internal and external key stakeholders: including Chemistry Manufacturing and Controls (CMC) team members and Contract Research Organizations (CROs), as well as corporate and collaborative partners, Regulatory Liaisons, vendor management and other cross-functional team members.
Responsible for supporting the tracking of Reference Safety Information (RSI) approvals by global health authorities. Additional responsibilities may include other documentation management needs for U.S. and other health authority submission activities.
- Responsible for tracking Clinical Trial Application (CTA) submission deliverables
- Manage CTA regulatory submission/document transfers between Regeneron and CROs. This can include scheduling meetings (Microsoft Teams) and applicable follow-up communication for deliverables.
- Downloading of CTA deliverables from numerous CRO web-based systems and communicating updates to key stakeholders in a timely fashion. Uploading will also include numerous tracking platforms to help obtain metrics and communicate study updates to other teams.
- Collect, upload and manage Regulatory Agency communications, in all formats (e.g. emails, Phone conversations, hard copy letters, etc.) within the Veeva Vault RIM document repository.
- Brief review of regulatory packages and tracking of any issues or gaps in data collection.
- Collaborates with the functional area team and key stakeholders
- Communicates key RSPM related information to consumers, collects feedback, and takes action
- Identifies and communicates regulatory system enhancement needs or technical issues