Principal Regulatory Writer

Principal Regulatory Writer An exciting opportunity has opened for a Principal Regulatory Writer to join a Global Rare Diseases R&D function, supporting the development and delivery of high-quality regulatory submissions across the full product lifecycle.This is a key role within a global, cross-functional environment, working closely with Regulatory Affairs, Clinical Development, Biostatistics, Safety/Pharmacovigilance, CMC, Medical Affairs and external partners. You will translate complex clinical, nonclinical and CMC data into clear, accurate and compliant regulatory documentation for global health authorities.The RoleYou will take ownership of regulatory writing activities across development and post-approval programmes, supporting submissions to agencies including the FDA, EMA, MHRA, NMPA and Health Canada.Key responsibilities include:Authoring, reviewing and finalising CTD Module 1 and Module 2 documents, including clinical and nonclinical summaries and overviews.Developing Health Authority meeting requests, briefing packages and regulatory response documents.Supporting responses to Questions, RFIs, Major Objections, Clarifaxes and Lists of Outstanding Issues.Preparing documentation for post-approval variations, extensions and lifecycle management activities.Supporting clinical development documents including clinical study protocols, CSRs and Investigator’s Brochures.Developing applications and designation packages for Orphan Drug, Fast Track, Breakthrough Therapy, RMAT, PRIME and other expedited/special regulatory programmes.Ensuring regulatory documentation meets relevant eCTD, ICH and regional regulatory requirements.Coordinating contributions from cross-functional SMEs and external regulatory writers, ensuring quality, consistency and delivery against timelines.Providing guidance on regulatory writing best practice, templates, SOPs, style guides and document standards.Supporting resource planning and providing subject-matter expertise across regulatory writing activities.RequirementsWe are looking for an experienced regulatory writer with:A relevant Life Sciences degree, PhD or PharmD; RAC qualification is desirable.Demonstrated experience authoring and/or leading regulatory documents across the drug development lifecycle.Strong experience with documents such as Health Authority briefing packages, CTD Module 2 summaries/overviews, regulatory responses, IND/CTA/NDA/BLA documentation and expedited programme applications.Strong knowledge of global regulatory frameworks, particularly FDA and EMA requirements.Advanced understanding of relevant ICH guidelines, including ICH E3, E6, E9 and M4.The ability to interpret complex clinical and statistical data and communicate it clearly within a regulatory context.Excellent written and verbal English communication skills.Strong organisational skills and the ability to manage multiple deliverables and tight timelines.Exceptional attention to detail, particularly around data consistency, traceability and cross-document alignment.Experience working within matrixed, cross-functional teams, with the ability to guide and mentor other writers and contributors.A background in rare diseases would be highly desirable.