Skip to Main Content

Job Title


Regulatory Labelling Consultant


Company : Walker Cole International


Location : Southampton, South East


Created : 2025-06-22


Job Type : Full Time


Job Description

Walker Cole are partnered with a leading pharmaceutical company in the UK that is looking to bring on board an experienced Regulatory Labelling Consultant. This is a fantastic opportunity for someone with a strong background in regulatory documentationparticularly SmPCs, PILs, and labelling complianceto join a high-performing regulatory affairs team.The information below covers the role requirements, expected candidate experience, and accompanying qualifications.Key Responsibilities:Lead the preparation, review, and maintenance of labelling documents including Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs), and packaging components.Ensure all labelling is compliant with MHRA and EMA regulations and reflects the most up-to-date product information.Collaborate with internal teams including Regulatory Affairs, Medical, Pharmacovigilance, and Artwork to manage labelling updates and submissions.Support labelling strategy for new product launches, variations, and lifecycle management activities.Monitor regulatory changes and assess their impact on product labelling.Maintain labelling systems and ensure documentation is audit-ready.What Were Looking For:A degree in Life Sciences, Pharmacy, or a related field.3+ years of regulatory labelling experience within the pharmaceutical industry.Strong working knowledge of SmPCs, PILs, and EU/UK labelling regulations.Familiarity with QRD templates, eCTD submissions, and labelling change control processes.Excellent attention to detail and the ability to manage multiple priorities.Strong communication and stakeholder engagement skills.Nice to Have:Experience with global labelling (e.g., US FDA).Knowledge of electronic labelling systems such as Veeva Vault or Documentum.Background in both branded and generic pharmaceuticals is a plus.