Job title: Technical Changes Labeling Specialist

Location: Budapest, Hungary

Flexible working: 60% home, 40% office

Job type: Permanent, full-time

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Join our Global Regulatory Affairs organisation as Technical Changes Labeling Specialist and you'll execute key regulatory related activities such as coordinate regulatory CMC and labeling strategies for Technical Changes Controls in support of the development and maintenance of Healthcare Provider and Patient labeling information.

• Perform regulatory evaluations within existing Sanofi Quality Management Systems / Change Control systems
• Coordinate and liaise with key stakeholders to define regulatory submission strategies- exchange data and information, monitor progress, take action, record action to coordinate and make progress with change processing
• Compile regulatory documents to support corporate publishing and dispatch submission processes
• Prepare global communications and information packages for local distribution
• Maintain regulatory requirements database in collaboration with Country Regulatory Heads
• Participate to the preparation / update of quality document, processes, tool enhancement and training materials
• Closely interact with colleagues in quality, performance, and business process/operational excellence roles to ensure optimal processes and tools are developed and implemented

• At least 2-3 year working experience within a regulatory affairs department in a global pharmaceutical company
• Tracking of regulatory activities in corporate database
• Understanding of the relationship between systems and electronic database, eCTD dossier requirements and change management in the pharmaceutical area, ideally for CMC changes and labeling changes

• Excellent verbal, written, organizational and interpersonal skills with a sharp attention to detail and the ability to handle multiple tasks simultaneously
• Collaborative team player with orientation towards building and maintaining effective relationships with strong cultural awareness
• Dedicated and persuasive "can-do" attitude and entrepreneurial spirit with a continuous improvement mindset
• Working knowledge in MS Office Suite (Outlook, Word, Excel, PowerPoint) and Change Control and Quality Management Systems
• Hands-on knowledge of Veeva Vault tools or web skills is a plus

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
• Work from an "Office of the Year 2023" award winner with flexible home office policy
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)