Pharmacien Senior Affaires Réglementaires - F/H
Core
Senior regulatory affairs consultant providing strategic regulatory and pharmaceutical advice for clients in the health industry, covering French, European, and international regulations.
Role type
Senior regulatory affairs consultant
Builds
Regulatory strategies for drug registration from development to marketing authorization (AMM), including variations, orphan designation, and early access programs.
Domain
Healthcare / Pharmaceutical Regulatory Affairs
Deliverable
client delivery
Required skills
Strategic regulatory consulting, drug lifecycle management, regulatory filing (AMM, PSUR, clinical trials), promotional document validation, project management, complex regulatory analysis
Preferred skills
Dual background in pharma industry and consulting, early access program expertise (AP1, AP2, AC, CPC)
Technologies
Regulatory databases, submission platforms
Responsibilities
Define and deploy regulatory registration strategies, prepare and submit regulatory dossiers to authorities, conduct deep analysis of regulatory files, validate promotional and non-promotional documents, act as senior technical project lead
Seniority
Senior, hands-on IC