Consultant Senior Affaires Réglementaires - F/H
Core
Senior regulatory affairs consultant providing strategic pharmaceutical and regulatory advice for clients in the health industry, covering French, European, and international regulations.
Role type
Senior IC 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
Required skills
Strategic regulatory and pharmaceutical consulting, regulatory registration strategy (pre- and post-AMM), early access program strategies, regulatory dossier analysis, compliance analysis for product information and labeling, regulatory submission preparation and follow-up, promotional document validation, complex project management, senior stakeholder coordination
Preferred skills
Dual background in laboratory and consulting firm, deep knowledge of the drug lifecycle, expertise in communication/promotion issues, high-level writing rigor
Technologies
Regulatory databases, submission platforms, project management tools
Responsibilities
Provide strategic regulatory and pharmaceutical consulting covering applicable regulations, Define and deploy regulatory registration strategies from development to AMM, Contribute to early access strategies (AP1, AP2, AC, CPC), Conduct in-depth analysis of regulatory dossiers and advise on compliance, Prepare and submit regulatory dossiers (AMM, variations, PSUR, clinical trials), Validate promotional and non-promotional documents, Participate in complex regulatory projects with health authorities, Act as a senior reference and technical project lead
Seniority
Senior, hands-on IC