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- Tasks: Lead the creation and review of regulatory labelling documents for pharmaceutical products.
- Company: Join a top-tier pharmaceutical company making waves in the UK market.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth.
- Why this job: Be part of a high-performing team impacting patient safety and product compliance.
- Qualifications: Degree in Life Sciences or Pharmacy; 3+ years in regulatory labelling required.
- Other info: Experience with global labelling and electronic systems is a bonus.
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. Being well-versed in these guidelines will not only boost your confidence but also demonstrate your commitment to compliance during interviews.
✨Tip Number 3
Consider reaching out to current or former employees of the company you're applying to. They can provide valuable insights into the company culture and expectations, which can help you tailor your approach during the interview process.
✨Tip Number 4
Prepare to discuss specific examples from your past experience that highlight your expertise in managing labelling documents and compliance. Use the STAR method (Situation, Task, Action, Result) to structure your responses effectively.
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 strong communication skills and ability to manage multiple priorities.
Highlight Collaborative Experience: Since the role involves collaboration with various internal teams, emphasise any past experiences where you successfully worked with cross-functional teams. This could include working with Regulatory Affairs, Medical, or Pharmacovigilance departments.
Showcase Attention to Detail: Provide examples in your application that demonstrate your attention to detail, especially in maintaining compliance with regulations and ensuring documentation is audit-ready. This will be crucial for the role and should be clearly articulated.
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
Since this role requires a keen eye for detail, consider bringing along samples of your previous work or documentation that showcase your meticulousness. Discuss how you manage multiple priorities while maintaining high standards in your work.
✨Prepare for Collaboration Questions
Expect questions about your experience working with cross-functional teams. Be ready to share examples of how you've collaborated with Regulatory Affairs, Medical, and other departments to manage labelling updates and submissions effectively.
✨Stay Updated on Regulatory Changes
Research recent changes in MHRA and EMA regulations before your interview. Being able to discuss how these changes could impact labelling will demonstrate your proactive approach and commitment to staying informed in the field.
