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- Tasks: Lead labelling document preparation and ensure compliance with regulations.
- Company: Join a top UK pharmaceutical company known for innovation and excellence.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth.
- Why this job: Be part of a high-performing team making a real impact in healthcare.
- Qualifications: Degree in Life Sciences or Pharmacy; 3+ years in regulatory labelling required.
- Other info: Experience with global labelling and electronic systems is a plus.
The predicted salary is between 36000 - 60000 £ per year.
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.
Regulatory Labelling Consultant employer: Walker Cole International
Contact Detail:
Walker Cole International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Labelling Consultant
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those working in regulatory affairs. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in labelling compliance.
✨Tip Number 2
Familiarise yourself with the latest MHRA and EMA regulations regarding labelling. Keeping up-to-date with regulatory changes will not only enhance your knowledge but also demonstrate your commitment to compliance during interviews.
✨Tip Number 3
Showcase your experience with SmPCs and PILs by discussing specific projects you've worked on. Be prepared to explain how you ensured compliance and managed updates, as this will highlight your practical skills in regulatory labelling.
✨Tip Number 4
If you have experience with electronic labelling systems like Veeva Vault or Documentum, make sure to mention it. Highlighting your familiarity with these tools can set you apart from other candidates and show that you're ready to hit the ground running.
We think you need these skills to ace Regulatory Labelling Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory labelling, particularly with SmPCs and PILs. Use specific examples to demonstrate your knowledge of EU/UK regulations and any experience with QRD templates.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention your 3+ years of experience in regulatory labelling and how it aligns with the responsibilities outlined in the job description. Be sure to include your familiarity with labelling compliance and collaboration with internal teams.
Showcase Your Attention to Detail: Since attention to detail is crucial for this role, consider including a brief section in your application that outlines how you ensure accuracy in your work. This could be through specific processes you follow or tools you use to maintain compliance.
Highlight Communication Skills: Given the importance of stakeholder engagement in this position, emphasise your communication skills in both your CV and cover letter. Provide examples of how you've successfully collaborated with cross-functional teams in previous roles.
How to prepare for a job interview at Walker Cole International
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of SmPCs, PILs, and the relevant EU/UK labelling regulations during the interview. Be prepared to discuss specific examples from your past experience where you ensured compliance with these regulations.
✨Demonstrate Attention to Detail
Given the importance of accuracy in regulatory documentation, share instances where your attention to detail made a significant difference. This could include examples of how you managed labelling updates or maintained audit-ready documentation.
✨Emphasise Collaboration Skills
Since the role involves working closely with various internal teams, be ready to discuss your experience in cross-functional collaboration. Highlight how you’ve successfully worked with Regulatory Affairs, Medical, and other departments to achieve common goals.
✨Stay Updated on Regulatory Changes
Show your proactive approach by discussing how you keep abreast of regulatory changes that impact labelling. Mention any resources or strategies you use to monitor these changes and how you've adapted labelling strategies accordingly.
