Global Regulatory Coordinator - Labelling/Artwork regional coordinator (French Speaking b2)

Global Regulatory Coordinator - Labelling/Artwork regional coordinator (French Speaking b2) -  Sanofi - Budapest

Working within the Global Regulatory Affairs-CHC, Strategic Regional Platform, in collaboration with Product Leaders, Analysts, Labelling, Zone coordinators, and Affiliates, you will be responsible for the management of labelling/administrative (Core Package 2) changes and artwork updates, regarding AMEA/EURASIA/EU (deferred countries).

This role requires B2 Level French speaking and would ideally suit a graduate in Biological/Chemical/Pharma

Main Responsibilities

Maintenance of labeling/administrative variations and artworks update:

strategy validation

preparation of labeling/administrative changes

assessing the impacted countries

gathering approvals, SmPC, PIL

requesting translation

requesting Ancillary documents

requesting legalization

dispatching the variation

update/review/validate the artworks

update of the regulatory database (Vault RIM)

filing and archives

This activity requires many contacts and collaboration within Regulatory Affairs CHC, other departments in the group and affiliates. Full training will be provided for this role.

When joining our team, you will experience:

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
• An attractive, market-oriented salary and cafeteria benefits
• Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days
• Work from an "Office of the Year 2020" finalist office
• Collective life and accident insurance
• Yearly medical check-up
• 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
• Your own career path within Sanofi. Your professional and personal development will be supported purposefully
• Practice your language skills within our "Language Club"
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

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.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.