Chargé(e) de Projet Réglementaire - all genders

CDI
Neuilly-sur-Seine
Salaire : Non spécifié
Télétravail non autorisé
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Sanofi
Sanofi

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Le poste

Descriptif du poste

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

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