Job offer Technical Regulatory Affairs Officer (M / F)

Joining Sanofi Compiègne means joining one of the nine centers LEAN World Academy. It hosts a production center of solid forms and an Industrial Innovation Development Center for the Allergy, Pain and Digestive categories.​

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Thanks to the application of a LEAN production system, the site demonstrates great performance in drug manufacturing intended for the general public.

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Sanofi, Compiègne (60 – Near Paris, around 50 minutes), industrial site specializing in the production of solid forms (tablets, capsules and powders), packaged in different formats (blisters, bottles and sachets) and sold worldwide ( Europe, Canada, USA, Japan, Export) is recruiting on fixed-term contracts until 12/31/2022, a a CMC technico-regulatory affairs manager (M / F).

MAIN MISSIONS

• Write and update the technical documentation (CMC parts, variations, response files to questions from the authorities, etc.) in line with the source data, the site’s strategy, country regulations while respecting a defined schedule
• Check regulatory compliance (practical site versus recorded information); and approve under certain conditions, the documentation used on the site with regard to the MA files (Manufacturing techniques, Control, Analysis Certificate frames, etc.)
• Ensure a “State of the Art” watch (compliance with ICH guidelines, technology watch, etc.)
• Ensure regulatory compliance products during its participation in projects, and transfers (in / out)
• Ensure the technical-regulatory assessment of changes provided by the site (Change Control)
• Ensuring communication from health authority approvals of changes to relevant implementation officials

REQUIRED SKILLS

• Recognized and significant technical and editorial experience in the field of regulatory affairs CMC Module 3 Quality
• Control of the regulatory environment [guidelines ICH, réglementation internationales (EU, US…)]
• Good knowledge of recording and filing strategies
• Fluency in written and spoken English essential
• Cooperate transversally with multiple interlocutors internal and external to the manufacturing site
• Knowing how to offer innovative solutions and demonstrate autonomy
• Team player, excellent interpersonal skills

CANDIDATE PROFILE

• Pharmacist – (thesis required), volunteer to work on the night shift
• Beginner accepted in the technical-regulatory field in the pharmaceutical industry

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.

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