Neuilly Sur Seine, France
2 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 auditImplement the regulatory strategy, coordinate, carry out and monitor the regulatory actions identified as part of the qualifications and registrations of suppliersCoordinate the routine implementation of suppliers within the teamDefine the strategy for maintaining “back-up” suppliersParticipate in the writing and maintenance of proceduresParticipate 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

Confirm your E-mail: Send Email
All Jobs from Sanofi Aventis