date published
05/15/2021
Type of Contract
Full time
job reference
R2593771
location
Compiegne, France
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Joining Sanofi Compiègne means joining one of the nine global centers of the LEAN Academy. It houses a Solid Forms Production Center and an Industrial Innovation Development Center for the Allergy, Pain and Digestive categories.
Thanks to the application of a LEAN production system, the site demonstrates a great performance in the manufacture of drugs intended for the general public.
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 aCMC technico-regulatory affairs manager (M / F).
MISSIONS
Reporting to the Regulatory Quality Assurance Manager within the Quality Department, your main mission will be the management of a product portfolio for which you ensure the regulatory compliance of CMC files submitted to health authorities, in compliance with the regulations in force and internal procedures while integrating industrial constraints.
The management of this diversified product portfolio involves various activities for the CMC technical-regulatory affairs manager who
- Writes and updates the technical documentation (CMC parts, variations, response files to questions from the authorities) in line with the source data, site strategy, country regulations while respecting a defined schedule
- Checks regulatory compliance (site practice versus recorded information); and approves under certain conditions the documentation used on the site with regard to the MA files (Manufacturing techniques, Control, Analysis Certificate frames)
- Ensures a “State of the Art” watch (compliance with ICH guidelines, technological watch)
- Ensures regulatory compliance of products during its participation in projects, and transfers (in / out)
- Ensures the technical-regulatory assessment of the changes planned by the site (Change Control)
- Ensures the communication of approvals of changes by health authorities to relevant implementation officials
- Advises and assists the departments concerned (supply, production, quality) on regulatory aspects of all kinds
CANDIDATE PROFILE
Education / Experience
- Pharmacist), or with a Bac +5 with additional training such as a master’s degree in technical-regulatory affairs
- Experience required of 3 to 5 years in similar functions
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), pharmacopées]
- Control of the constitution of files
- 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
- Fluency in written and spoken English essential
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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