The Regulatory Affairs Services Senior Manager is responsible for either Regulatory Strategy, all aspects of publishing and submission of clinical and regulatory documents or a combination of both. You'll serve as the primary regulatory contact for clients with responsibility for managing regulatory timelines and resources to achieve client deliverables on time and within budget. You'll represent Regulatory Affairs Services on project teams both internally and externally providing strategic input; works closely with senior regulatory staff to plan, prioritize and coordinate regulatory document preparation and submission based on applicable global regulations. Working closely with regulatory affairs senior management, assumes a leadership role in the research, development, vendor management and implementation of electronic regulatory submissions capability for client documents and applications. Additionally, You'll identify the need for Regulatory Affairs standard operating procedures (SOPs), guidelines and work instructions, assists with their preparation and with staff training.