Regulatory Program Specialist

About the role

Roche is seeking a Regulatory Program Specialist to act as an individual contributor within its global regulatory team. The role focuses on planning, tracking and executing regulatory submissions worldwide, ensuring compliance and supporting the “one submission, one approval” strategy.

Key responsibilities

• Plan, track and monitor key regulatory information globally to ensure compliance and timely submission execution.
• Develop and implement regulatory data strategies and configure submission data in regulatory information management systems.
• Perform end‑to‑end submission support, including editing and formatting eCTD documents to Roche standards, managing document flow and version control in the DMS.
• Collaborate with cross‑functional teams, external vendors and technical SMEs to deliver content on schedule.
• Provide input for system enhancements, business process updates and continuous‑improvement initiatives.
• Serve as Business Process Owner or Subject Matter Expert for specific regulatory information activities, maintaining regulatory master data and delivering training.

Required profile

• Strong knowledge of Roche regulatory guidelines, applicable laws and best practices.
• Ability to perform complex system searches, prepare analytical reports and assemble documentation.
• Proven experience building trusted relationships across departments and with external regulators.
• Mentoring capability for junior colleagues and a continuous‑improvement mindset.

Required skills

• eCTD formatting and submission preparation.
• Regulatory Information Management (RIM) systems.
• Document Management System (DMS) usage and version control.
• Regulatory master data management and data governance.
• Experience working with external vendors and submission tools.

What we offer

• Opportunity to work in a global, innovative pharmaceutical environment.
• Collaboration with cross‑functional teams and exposure to worldwide regulatory processes.