Experteer Overview In this role you will author, review, and manage regulatory documents that translate clinical, nonclinical, and CMC data into compliant submissions for global authorities. You will serve on cross‑functional teams to ensure scientific rigor and regulatory alignment across the product lifecycle. You’ll oversee document development for marketing applications and lifecycle updates, while guiding external writers and internal experts. This is a chance to shape regulatory strategy for rare diseases within a mission‑driven, globally integrated environment.
Retribuzione / Benefits Draft, review, and finalize regulatory and clinical documents (CTD Modules 1-2 and related addenda)
Coordinate post‑approval variations and lifecycle documentation
Prepare regulatory response documents (RFI, questions, objections) and designation/expedition requests
Develop and maintain clinical study protocols and reports, investigator brochures
Ensure eCTD compliance and alignment with ICH/FDA/EMA guidelines




Lead and coordinate external writers and internal SMEs; mentor junior writers
Support dossier assembly, timelines, and cross‑functional inputs; contribute to resource planning and budgeting
Train contributors on regulatory writing standards, styles, and traceability
Responsabilità Life science university degree; PhD or PharmD preferred
Experience authoring/regulatory writing across drug development lifecycle
Knowledge of FDA/EMA requirements and ICH guidelines (E3, E6, E9, M4)
Ability to interpret clinical/statistical data for regulatory submissions
Fluent English, strong written and verbal communication
Experience with cross-functional team leadership and project management
Proficient in MS Office and Adobe Acrobat; familiarity with eCTD publishing
Requisiti fondamentali pension
private medical insurance
wellbeing programme
flexible benefits programme
relocation support
annual premio

#J-18808-Ljbffr

📌 Principal Regulatory Writer, Global Rare Diseases (Parma)
🏢 Altro
📍 Parma