G&L Scientific is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance consultancy work – and we are rapidly growing! Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements are exceeded.You'd be joining our international team of experienced Regulatory professionals who manage multiple global projects for a wide variety of clients – from giant pharma to niche biotechs. We are a leading consultancy firm with offices on three continents, and we are building our specialist team of consultants with knowledge of medical devices, diagnostics, and combination products. Our team works closely with a wide range of clients from start-ups to established companies, helping them navigate the complex regulatory landscape and bring innovative products to market. Our projects cover everything from cutting-edge medical devices to companion diagnostics and combination products.Evaluate change controls and provide regulatory insights on quality changes in production and quality control.Review study reports (like process validation, stability studies, analytical method validation) from quality control and production to ensure everything meets regulatory standards.Work with teams across manufacturing, supply chain, quality control, quality assurance, and other regulatory departments to coordinate submission preparation.Write or review submission content to make sure it aligns with regulatory requirements (for variations and health authority questions).Knowledge of regulatory processes, systems, and guidelines (like quality control, stability, process validation, and comparability studies).Excellent written and spoken English.Proficiency in a local language (depending on location: French, Italian, or German).Have strong writing and analytical skills, with a keen attention to detail.Experience in regulatory affairs (especially in technical/CMC/quality) within the pharmaceutical industry.Experience writing CMC (technical) sections for regulatory documents (registration files or variations).Experience in validation, Quality Assurance, or production, with experience preparing regulatory documents.Proficient in Word, PowerPoint, Excel; familiarity with Veeva Vault is a plus.Fluent in English and depending on location, French, German, or Italian.