Regulatory Labelling Consultant

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.