Europe Regulatory Medical Writing Lead

Revolution Medicines; Basel; Hybrid; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

Revolution Medicines is seeking an experienced Principal Regulatory Medical Writer to lead the preparation of regulatory documentation for clinical development and marketing authorization across Europe. You will collaborate with Regulatory Affairs, Clinical Development, and cross-functional teams to author, coordinate and finalize submissions.

The role reports to the VP, Regulatory Affairs, Europe. You will serve as lead author for complex regulatory documents, ensuring scientific accuracy,

Qualifikationen

• Advanced degree in life sciences or related field.
• Minimum 10+ years of regulatory medical writing experience.
• Experience supporting European regulatory submissions (CTA/MAA).
• Strong command of English, excellent writing/editing skills.

Aufgaben

• Author, edit and coordinate regulatory documents for European approvals.
• Respond to Health Authority questions (EMA/MHRA/Swissmedic).
• Lead complex regulatory documents (protocols, IBs, CSRs, CTAs).
• Coordinate responses for information requests; ensure consistency across teams.
• Mentor junior writers and improve medical writing processes.
• Ensure ICH/EMA/GCP compliance and document templates are followed.

Kenntnisse

Regulatory writing

European submissions

ICH guidelines

Project management

Cross-functional collaboration

English proficiency

Ausbildung

PhD/PharmD/MD/MSc or equivalent

Tools

Veeva Vault RIM

StartingPoint

EndNote

SmartSheet

Jobbeschreibung

Revolution Medicines is seeking an experienced Principal Regulatory Medical Writer to lead the preparation of regulatory documentation for clinical development and marketing authorization across Europe. You will collaborate with Regulatory Affairs, Clinical Development, and cross-functional teams to author, coordinate and finalize submissions.

The role reports to the VP, Regulatory Affairs, Europe. You will serve as lead author for complex regulatory documents, ensuring scientific accuracy,