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?

We are currently on a journey where we are transforming how we support our Global Regulatory Affairs (GRA) teams and are looking for team members who can join us on this exciting journey.

Join us as Labeling Specialist to execute key labeling related activities in support of the development and maintenance of Healthcare Provider and Patient labeling information. You will be a critical member of a highly productive global labeling and artwork content team, a collaborative team player, and driven to problem solve and improve ways of working.

The successful candidate for this role is driven to do something meaningful and having impact on people’s health and well-being.

Main responsibilities:

• 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.

About you

Experience:

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

Soft skills:

• 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.
  

Technical skills:

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

Education:

• Min. Bachelor’s degree, or equivalent.

Languages

• Excellent written and verbal communication skills in English.

Why choose us?

• 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)

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.

#Sanofi #SanofiCareers #joinSanofi

#jobopportunities #careeropportunities #sscjob

#Sanofi_Budapest_Hub #Budapest

#Regulatory #regulatoryaffairs #labeling #labelingspecialist #regulatorylabeling

#LI-EUR #LI-hybrid

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!