Regulatory Affairs Specialist – 1-year temporary contract

About the role

Roche is seeking a Regulatory Affairs Specialist on a one‑year temporary contract. The role supports global regulatory planning, data strategy, and submission activities, ensuring compliance with internal and external requirements.

Key responsibilities

• Plan, track and monitor key regulatory information worldwide to guarantee compliance and timely submissions.
• Develop and implement regulatory data strategies, configuring data in regulatory information management systems.
• Execute end‑to‑end submission support, including editing and formatting technical documents (eCTD) to Roche/HA standards.
• Coordinate document flow, version control in the Document Management System, and collaborate with cross‑functional teams.
• Maintain regulatory master data, create process documentation, and deliver training as needed.
• Work with external vendors and use submission/RIM tools to manage regulatory data across regions.

Required profile

• In‑depth knowledge of Roche and global regulatory guidelines, laws and best practices.
• Proven ability to perform complex system searches, prepare reports and assemble documentation.
• Strong relationship‑building skills across departments and with external partners or regulators.
• Experience mentoring junior colleagues and handling sensitive regulatory cases.

Required skills

• eCTD preparation and formatting
• Regulatory Information Management Systems (RIM)
• Document Management System (DMS) usage
• Submission tools and technologies
• Data governance and master data management

What we offer

• Opportunity to work within a global pharmaceutical leader.
• Exposure to cross‑functional teams and cutting‑edge regulatory processes.
• Professional development in a supportive, inclusive culture.