Principal Regulatory Writer, Global Rare Diseases

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

• pension
• private medical insurance
• wellbeing programme
• flexible benefits programme
• relocation support
• annual bonus

Responsabilità

• 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

Requisiti fondamentali

• 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
• exceptional written and verbal communication
• highly organized and proactive
• attention to detail
• global regulatory frameworks (FDA, EMA)
• ICH guidelines (E3, E6, E9, M4)
• regulatory writing best practices and templates