Chargé(e) de Projet Réglementaire - all genders
Sanofi
Date: il y a 3 jours
Ville: Neuilly-sur-Seine, Île-de-France
Type de contrat: Temps plein
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
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
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
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
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