About this role

Provides regulatory expertise and guidance on procedural and documentation requirements
Liaises with clinical, commercial and other internal business partners
Contributes to the development of a harmonized regulatory voice at Sanofi
Proactively contributes with curiosity and openness to diverse perspectives
Develops, executes and maintains submission content plans
Effective communication and ability to manage multiple projects/deliverables simultaneously

BS/BA degree in a scientific discipline required (e.g. Biology, Life Science, or related field)
Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred
At least 6 years of relevant pharmaceutical/biotechnology industry experience
At least 6 years of relevant Regulatory Affairs experience or 2 years with an advanced degree
Understanding of clinical development of drugs and/or innovative biologics products is preferred
Demonstrated experience with driving the preparation of regulatory documents (e.g. (s)BLA/(s)NDA/MAA, INDs/CTAs)
Experience with electronic document management systems (e.g. Veeva Vault, Plai) is desirable

Regulatory Strategist

Key skills