Regulatory Labeling Specialist - VIE contract

Regulatory Labeling Specialist – VIE contract

• Location: Hungary, Budapest
• Hiring Manager: Javier CEDRON CASTRO
• Target start date:01/01/2025

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.

About the job

Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As Regulatory Labeling SpecialistVIE in our Regulatory Affairs team, you’ll execute key regulatory related activities such as coordinate regulatory labeling strategies supporting of the development and maintenance of Healthcare Provider and Patient labeling information. The Sanofi Global Regulatory Affairs Regulatory Labeling Specialist VIE will be a critical member of a highly productive team, a collaborative team player, and driven to problem solve and improve ways of working.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

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.
• Monitor KPI’s (Key Performance Indicators) 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, and record action as per legal agreement and internal SOPs (Standard Operating Procedures).
• Update and maintain labelling 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 in 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:

• 1+ year of experience in a similar field or in pharma industry.

Soft and Technical skills:

• Problem solving and critical thinking skills.
• Collaborative team player with orientation towards building and maintaining effective relationships, and strong cultural awareness.
• Ability to communicate effectively, verbally and written, across varying functions and levels of management.
• Dedicated and persuasive “can-do” attitude and entrepreneurial spirit. Willingness to learn.
• Ability to operate with agility in a dynamic global environment.
• Ability to maintain discretion and confidentiality about sensitive data, and to ensure data readiness.
• Working knowledge Microsoft Office & Windows (Outlook, Word, Excel, PowerPoint), web skills a plus.
• Project management and/or coordination experience is a plus.

Education:

• Bachelor’s degree or equivalent, preferably in the pharma or life sciences fields.

Languages:

• English proficiency at a professional level is required (verbal and written).

Why choose us?

iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.

Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.

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, gender identity or Veteran status.

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

#LI-EUR