Principal Regulatory Writer, Global Rare Diseases
Department: GRD Regulatory Affairs
Business Area: R&D;, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type: Permanent
Location: Parma, IT
What we are looking for
This is what you will do
Within the Global Rare Diseases, R&D;, Regulatory Affairs and reporting to the VP, Global Regulatory Affairs, Global Rare Diseases the Principal Regulatory Writer is responsible for authoring, reviewing, and managing regulatory documents that translate clinical, nonclinical and CMC data into clear, accurate, and compliant submissions for global health authorities (e.g., FDA, EMA, MHRA, NMPA, Health Canada), supporting both initial marketing applications and post‐approval lifecycle activities for drugs and biological products.
They serve as a central member of cross‐functional regulatory submission teams, working in close collaboration with Global and Regional Regulatory Leads, Clinical Development, Biostatistics, Safety/Pharmacovigilance, CMC, Medical Affairs, and external partners to ensure consistency,



scientific rigor, and regulatory alignment.
They are accountable for document development across the full product lifecycle, including original applications, variations/supplements, responses to regulatory questions, periodic updates, and other post-approval life cycle management documents.
They provide coordination, oversight, and guidance for regulatory writing activities across Global Rare Disease (GRD) development programs, ensuring harmonization of messaging and adherence to global standards.
You will be responsible for
Oversee the drafting, review, and finalization of key regulatory and clinical documents, including but not limited to:
CTD Module 1 and 2 documents, including 1.6.1 and 1.6.2 (Meeting requests and packages).
2.4, 2.5, 2.7.3, 2.7.4, 2.7.5, 2.7.6, etc. (e.g., Nonclinical and Clinical summaries and overviews).
Addenda, updates, consolidation, and alignment of Module 2 documents required to

📌 Principal Regulatory Writer, Global Rare Diseases (Italia)
🏢 Biotecnologie - Farmacia - Chimica
📍 Italia