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 documentation—particularly SmPCs, PILs, and labelling compliance—to join a high-performing regulatory affairs team.
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 We’re 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.