Regulatory Program Specialist (Temporary-Secondment)

About the role

Accountable for global planning, tracking, and monitoring of key regulatory information to ensure internal/external compliance and effective execution of submissions. Participate in developing and implementing the regulatory data strategy and configuring submission data in regulatory information management systems, including partnering with PT, PD, pRED and gRED to enable a single regulatory data strategy and data flow across the systems environment. Execute end-to-end submission-support activities: perform defined steps in the submission process, edit/format technical documents (e.g., eCTD) to Roche/HA standards, coordinate document flow and version control in DMS, and partner with PTR Squad Members to plan, track, and deliver content on time while liaising with technical SMEs. Contribute to continuous improvement by providing input on future system enhancements, business process updates, submission model documents, and by managing/reporting regulatory data across regions and sites, including work with external vendors (e.g., OBE Vendor Alliance) and use of submission/RIM tools and technologies. Serve as Business Process Owner and/or Subject Matter Expert for specific regulatory information activities and technologies, including defining and maintaining regulatory master data to uphold Roche/HA data governance standards globally, developing process documentation, and delivering training as needed. A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together. Roche is an Equal Opportunity Employer.