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- Tasks: Lead the creation and review of regulatory labelling documents for pharmaceutical products.
- Company: Join a top UK pharmaceutical company known for its innovative approach and high-performing teams.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Be part of a dynamic team impacting patient safety and product compliance in the healthcare sector.
- Qualifications: A degree in Life Sciences or Pharmacy and 3+ years of regulatory labelling experience 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: LinkedIn
Contact Detail:
LinkedIn Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Labelling Consultant
✨Tip Number 1
Familiarise yourself with the latest MHRA and EMA regulations. Understanding these guidelines will not only help you in interviews but also demonstrate your commitment to compliance, which is crucial for a Regulatory Labelling Consultant.
✨Tip Number 2
Network with professionals in the regulatory affairs field. Attend industry events or join relevant online forums to connect with others who can provide insights or even refer you to opportunities within their organisations.
✨Tip Number 3
Showcase your experience with SmPCs and PILs in conversations. Be prepared to discuss specific projects where you successfully managed labelling updates or compliance issues, as this will highlight your expertise to potential employers.
✨Tip Number 4
Stay updated on regulatory changes that could impact labelling. Subscribe to industry newsletters or follow relevant regulatory bodies on social media to ensure you're always informed, which can set you apart from other candidates.
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 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 eCTD submissions and labelling change control processes.
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 methodologies or tools you use to maintain compliance with regulations.
Highlight Collaboration Skills: The job requires collaboration with various internal teams. In your application, provide examples of how you've successfully worked with cross-functional teams in the past, particularly in managing labelling updates and submissions.
How to prepare for a job interview at LinkedIn
✨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, be ready to provide examples that showcase your attention to detail. You might want to mention any processes you have implemented to ensure that labelling documents are audit-ready.
✨Prepare for Collaborative Scenarios
Since the role involves working closely with various internal teams, think of instances where you successfully collaborated with others. Be prepared to discuss how you managed stakeholder engagement and communication in those situations.
✨Stay Updated on Regulatory Changes
Show your proactive approach by discussing how you keep yourself informed about regulatory changes that could impact labelling. Mention any resources or networks you utilise to stay current in the field.
