At a Glance
- 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: 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 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.
Showcase Your Attention to Detail: Since attention to detail is crucial for this role, consider including a brief example in your application that illustrates how you successfully managed multiple priorities while ensuring compliance with labelling regulations.
Highlight Collaboration Skills: Emphasise your ability to work collaboratively with various teams such as Regulatory Affairs and Medical. Provide an example of a successful project where you engaged stakeholders to achieve a common goal.
How to prepare for a job interview at LinkedIn
✨Know Your Regulatory Framework
Make sure you have a solid understanding of the MHRA and EMA regulations. Be prepared to discuss how these regulations impact labelling documents like SmPCs and PILs, as this will demonstrate your expertise in regulatory compliance.
✨Showcase Your Experience
Highlight your previous experience with regulatory labelling, especially any specific projects you've worked on. Discuss your familiarity with QRD templates and eCTD submissions, as this will show that you can hit the ground running.
✨Emphasise Collaboration Skills
Since the role involves working with various internal teams, be ready to share examples of how you've successfully collaborated with others in the past. This could include working with Regulatory Affairs, Medical, or Pharmacovigilance teams.
✨Stay Updated on Regulatory Changes
Demonstrate your proactive approach by discussing how you keep abreast of regulatory changes and their implications for product labelling. This shows that you're not just reactive but also forward-thinking in your role.