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- Tasks: Lead the creation and review of essential labelling documents for pharmaceutical products.
- Company: Join a top-tier pharmaceutical company known for innovation and excellence.
- Benefits: Enjoy a contract role with potential for remote work and professional growth.
- Why this job: Be part of a dynamic team making a real impact in healthcare through regulatory compliance.
- Qualifications: Requires a degree in Life Sciences or Pharmacy and 3+ years in regulatory labelling.
- 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 regulatory affairs field, especially those who have experience with labelling compliance. Attend industry events or webinars to connect with potential colleagues and learn about the latest trends in regulatory documentation.
✨Tip Number 2
Familiarise yourself with the specific regulations set by the MHRA and EMA. Understanding these guidelines 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 in conversations with recruiters. Be prepared to discuss specific projects where you successfully managed labelling updates or submissions, highlighting your attention to detail and ability to handle multiple priorities.
✨Tip Number 4
If you have experience with electronic labelling systems like Veeva Vault or Documentum, make sure to mention it. This knowledge can set you apart from other candidates and show that you're up-to-date with modern labelling practices.
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 labelling regulations.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the pharmaceutical industry. Mention your experience with compliance and collaboration with internal teams.
Highlight Key Skills: Emphasise your attention to detail, communication skills, and ability to manage multiple priorities. These are crucial for the role and should be evident in both your CV and cover letter.
Showcase Continuous Learning: If you have any additional certifications or training related to regulatory affairs or labelling, be sure to include them. This shows your commitment to staying updated in the field.
How to prepare for a job interview at Walker Cole International
✨Know Your Regulatory Frameworks
Familiarise yourself with the MHRA and EMA regulations, as well as the specific requirements for SmPCs and PILs. Being able to discuss these frameworks confidently will demonstrate your expertise and preparedness for the role.
✨Showcase Your Documentation Skills
Prepare examples of your previous work with regulatory documentation. Highlight your experience with labelling compliance and any specific projects where you led the preparation or review of labelling documents.
✨Emphasise Collaboration Experience
Since the role involves working with various internal teams, be ready to discuss your experience in cross-functional collaboration. Share specific instances where you successfully managed labelling updates and submissions with different departments.
✨Stay Updated on Regulatory Changes
Demonstrate your proactive approach by discussing how you keep abreast of regulatory changes and their potential impact on product labelling. This shows your commitment to maintaining compliance and your ability to adapt to new information.
