Senior Regulatory Writer

Your new company An innovative and rapidly growing biotechnology organisation is seeking a Senior Manager, Regulatory Medical Writing, to join its expanding development team. Operating within a highly collaborative and science-driven environment, the company is focused on advancing a diverse pipeline of therapies through clinical development and regulatory approval. Your new role As Senior Manager, Regulatory Medical Writing, you will lead the development of high-quality regulatory documents across the product life cycle, supporting submissions from early clinical development through to marketing applications. You will work closely with cross-functional teams including Regulatory Affairs, Clinical Development, Medical Affairs, Pharmacovigilance, and Translational Medicine to ensure scientific accuracy, consistency of messaging, and regulatory compliance. You will also coordinate external medical writing resources and contribute to regulatory strategy discussions. What you'll need to succeed Proven experience within Regulatory or Medical Writing in the pharmaceutical or biotechnology industry. Strong experience authoring Clinical Study Reports (CSRs), Clinical Protocols, Investigator Brochures (IBs), and Health Authority Briefing Documents. Knowledge of global regulatory requirements and submission processes. Experience supporting IND, CTA, BLA, MAA and eCTD submissions. ...