EU Strategic coordinator
Company
Sanofi U.S.
Location
Athens, Greece
Type
Full Time
Job Description
About the job
Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As EU Strategic Coordinator within our Regulatory Excellenceteam, you'll ensure continuous improvement of E2E processes& being proactive and solution-focused regarding any new proposal of automation, digitalization, or simplification.
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.
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Main responsibilities
- Ensure Maintenance and optimization of the existing sharepoints (more than 10 Sharepoints in total to maintain)
- Creation of new Sharepoints when needed
- Prepare and Manage all training for PLM Portal (optimization of wows for the EU platform to embrace CHC needs)
- Weekly meetings with PXL , control/explanation/ amelioration for the WoW , ongoing/new /upcoming varaitions
- Veeva reports creation /maintenance
- Manage Article 23 reports and set up a wow to ensure notification occurs at local level : veeva reports, table cleaning , affiliates contact
- Manage CmdH notifications - Upcoming WS from the SRF extract ( to be able to communicate earlier at the beg of the LRC approval)
- Coordinates Renewals preparation for MRP/DCP : integrate way of working of renewals into the EU platform
- Manage ESPM portal at EU level
- Execute regulatory intelligence of EMA website/ PLM portal and attend all necessary meeting from EMA with regards to the implementation of PLM portal and shortages notification portal ESMP
About you
- Bachelor of Science or equivalent required in science or engineering, Master of Science preferred for this position. Pharmacy degree preferred.
- Minimum of 5 years in pharmaceutical industry with demonstrated experiences in European regulatory affairs.
- Good level of understanding of regulatory procedures as well as EtoE process
- Ability to think strategically and to translate business and technical objectives into roadmaps, projects and data strategies to support foundation and evolution of capabilities and platforms
- Collaborative approach and ability to cooperate transversally and to act for change for Regulatory
- Ability to lead and drive and to thrive in a fast-paced team environment
- Excellent interpersonal skills, negotiation skills, and verbal and written communications
- Must be able to quickly accommodate to changing priorities, and also to meet tight deadlines while maintaining high quality standards
- Proactivity, Experience in problem - solving and analysis. Ability to multi-task and to work in a global team environment, customer focused and action oriented.
- Understanding of organizational and inter-cultural sensitivities and able to apply this knowledge to day-to-day practices.
- Good networking ability
- Ability to resolve issues and proactivity.
- Fluent in spoken and written English
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
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
Date Posted
12/19/2024
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