Job title: Regulatory 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. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

• Prepare global communications and information packages for local distribution.
• Monitor country generic product reference labels for updates and liase with content owners to take action; KPI's by running reports, collating data and report as per oversight and governance process.
• Exchange information with partners; Read and understand agreements, monitor, take action, triage, record action as per legal agreement and internal SOPs.
• Update and maintain labeling and other associated components including version control, review and approval, coordinating translation requests if needed and coordinating content owner review of materials for feedback and revision.
• Enter associated data into Sanofi systems required by internal SOPs and policies (#BeDataReady).
• Monitor local/regional Health Authority approvals for coordination of translations/further dispatch.
• Participate to the preparation / update of quality document, processes, tool enhancement and training materials pertaining to role.
• Present data and information to key leaders / stakeholders for decision making and action.
• Closely interact with colleagues in quality, performance and business process/operational excellence roles to ensure optimal processes and tools are developed and implemented.

• 2+ years of experience in the pharmaceutical industry or equivalent.
• Understanding of the relationship between systems and electronic databases.

• Excellent verbal, written communication, organizational and interpersonal skills with a sharp attention to detail and the ability to handle multiple tasks simultaneously.
• Established ability to problem solve user issues.Demonstrated critical thinking.
• Collaborative team player with orientation towards building and maintaining effective relationships, strong culture awareness.
• Ability to work under pressure, adaptability to change, solve problems and willingness to learn to drive to meet short deadlines and shifting priorities.
• Demonstrated continuous improvement mindset.
• Dedicated and persuasive "can-do" attitude and entrepreneurial spirit.
• Ability to embrace new activities, willingness to learn.
• Ability to work with multifunctional and multicultural teams, to operate with agility in a dynamic global environment.
• Ability to maintain discretion and confidentiality about sensitive data.
  

• Working knowledge in Microsoft Office and Windows (Outlook, Word, Excel, PowerPoint), web skills are a plus.
  

• Min. Bachelor's degree, or equivalent.

• Excellent written and verbal communication skills in English.

• 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)