Regulatory Affairs Coordinator
Budapest, Hungary Permanent Date posted 28/06/2024Job title:Regulatory Affairs Coordinator with French
About the job
Within the International Region, in collaboration with Product Leaders, Regional coordinators and affiliates, you will be responsible for the technical and regulatory coordination of the activities. You will participate in the management of regulatory activities related to new registrations and maintenance of marketing authorizations in the concerned countries.
At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.
Main responsibilities:
Actively participate in the preparation files and management of renewals, registrations, variations and calls for tenders.
- administrative support: support the preparation of administrative documents:
- requesting signature, legalization, translation
- sending hard copies to affiliates
- filing and archives
- organization of meeting, updating contact list…
- support for preparation of renewals dossiers
- requesting Ancillary documents, gathering other statement and required documents
- completing eTOC/SCP
- sending hard copies
- support for preparation of labeling variations
- assessing the impacted countries
- gathering approvals, SmPC, PIL
- requesting translation / Ancillary documents / legalization
- dispatching the variation
- updating / reviewing / validating the artworks
- updating of the regulatory database (Vault RIM)
- others: support for registrations, surveys of subsidiaries, regulatory monitoring, etc.
This activity requires many contacts and collaboration within Scientific Affairs CHC, other departments in the group and affiliates.
About you
- Experience: 1 – 2 years in Regulatory service and/or in an international environment
- Knowledge in legal, regulatory affairs
- Excellent computer skills: Office package (Word, Excel, Powerpoint)
- Knowledge of Vault RIM, Vista is a plus.
- Organized, management of priorities, ability to work with accuracy and rigor, curiosity
- Ability to anticipate, reactivity, adaptability, flexibility
- Relational sense, open-minded and ability to adapt to different environments and cultures.
- Ability to work as a team in a dynamic and transversal environment
- Education: Life Sciences master’s degree, Regulatory, Pharmaceutics law, Pharmacy or similar
- Languages: English and French (B1 minimum)
Why choose us?
- 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 50% 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)
PursueProgress. 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!
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