Specialist, Regulatory Business Operations

Responsible for supporting the Regulatory Business Operations function with development and maintenance of department regulatory processes and critical regulatory submissions toolkit infrastructure. Support cross‑functional interactions with internal and external stakeholders to ensure regulatory needs and expectations are appropriately maintained for established partnership‑level CROs.

• Develop and maintain departmental regulatory processes (e.g., SOPs, templates, guidelines, etc.), including new and revised cross‑functional procedures
• Contribute to regulatory review and provide input for new and revised cross‑functional procedures
• Support maintenance and deployment of critical regulatory submissions toolkit infrastructure (e.g., Smartsheet submission timeline(s), Smartsheet Content Plan/Document Tracker, Veeva RIM Content Plan updates post handoff from Regulatory Operations)
• Assist in monitoring ...