Preparation of technico-regulatory cmc documentation
Support for variation and renewal registrations
As an alternant in the Regulatory Affairs CMC department, you will contribute to ensuring compliance with current regulations and participate in drafting CMC variation dossiers
Job Summary
As an alternant in the Regulatory Affairs CMC department, you will contribute to ensuring compliance with current regulations and participate in drafting CMC variation dossiers.
Sanofi offers an environment where you can learn freely, ask questions, and bring your ideas to life supported by inspiring mentors and collaborative teams.
The company provides attractive remuneration, social benefits, 31 days of annual leave, and up to 5 paid exam preparation days depending on the apprenticeship contract.
Matching Summary
As an alternant in the Regulatory Affairs CMC department, you will contribute to ensuring compliance with current regulations and participate in drafting CMC variation dossiers.
Skills & Requirements
Must-have
Regulatory compliance of manufactured products
Preparation of technico-regulatory CMC documentation
Support for variation and renewal registrations
Data collection collaboration with teams
Analytical chemistry knowledge
Good manufacturing practices (BPF)
Nice-to-have
Rigor and autonomy
Adaptability
Mentorship and collaborative teams
Digital innovation and continuous learning
Inclusive and flexible work environment
Key Requirements
Experience in Regulatory Affairs CMC
Bac+5/6 in regulatory affairs, pharmacy or scientific field