Neuilly Sur Seine, FRA
13 days ago
Chargé(e) de Projet Réglementaire - all genders
_Opella_ _, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market._ _We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet._ _That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core._ _Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands._ _This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers._ _We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification._ _Join us on our mission. Health. In your hands._ **Missions:** + Participate in the selection of suppliers of Materials for Pharmaceutical Use by carrying out the documentation audit + Implement the regulatory strategy, coordinate, carry out and monitor the regulatory actions identified as part of the qualifications and registrations of suppliers + Coordinate the routine implementation of suppliers within the team + Define the strategy for maintaining “back-up” suppliers + Participate in the writing and maintenance of procedures + Participate in health authority inspections **Main activities:** Active participation in project meetings, change committees, assessment of changes, assessment and review of project-related documentation, update of regulatory files and monitoring of submissions, responses to questions from authorities **Profile:** + Diploma in Chemistry or Pharmacy or experience of at least 3 years in Regulatory Affairs in the field of the pharmaceutical industry + Master of Regulatory Affairs + CMC writing experiences (Module 3) + Operational Quality Assurance knowledge (supplier audits, complaints, deviations, CAPAs, change management) + Professional English written and spoken + Organizational qualities, rigor, strength of proposal **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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