Preparation, writing, review and submission of Marketing Authorization (MA) dossiers (national procedures, DCP, MRP, centralized procedure)
Management of interactions with health authorities (ANSM, EMA, FDA)
Responding to agency queries and coordinating dossier supplements
Management of variations (type IA, IB, II) and MA renewals
Product lifecycle follow-up (PSUR, RMP, change notifications, etc.)
Contribution to registration strategies from early development phases
Writing CTD sections (Modules 1, 2 and 3)
Review of manufacturing, quality control and clinical trial documents for regulatory compliance
Participation in international product registrations (Africa, LATAM, Middle East, Asia…)
Regulatory intelligence on European and international legislation
Training and support for internal teams and clients

Pharmacist (Pharm.D. or equivalent) with specialization in regulatory affairs, health law or a complementary qualification (Master's level) preferred
Experience in regulatory affairs, ideally in a pharmaceutical company or CRO
Good knowledge of European (EMA), French (ANSM) and international (FDA, ICH) requirements
Proficiency with the CTD/eCTD format and electronic submission systems
Ability to manage multiple projects in parallel
Strong writing skills, rigor, autonomy and client focus
Good professional level of English (spoken and written)

Consultant – Pharmacist, Regulatory Affairs

About this role