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For Companies At a Glance
- Tasks: Ensure accurate and compliant product labelling across global markets.
- Company: Join a leading global biopharmaceutical organisation with a focus on patient safety.
- Benefits: Competitive salary, career development opportunities, and a collaborative work environment.
- Why this job: Make a real impact on patient safety and regulatory compliance in the biopharmaceutical industry.
- Qualifications: Degree in life sciences and experience in regulatory labelling within pharma or biotech.
- Other info: Work in a dynamic, global team with opportunities for growth and learning.
The predicted salary is between 36000 - 60000 £ per year.
We are currently supporting a global biopharmaceutical organisation in the search for a Global Labelling Specialist to join their UK-based Regulatory Affairs team. This role sits within Global Regulatory Affairs and plays a key part in ensuring that product labelling is accurate, compliant, and implemented effectively across global markets, supporting patient safety and regulatory compliance throughout the product lifecycle.
Key Responsibilities
- Support the development, maintenance, and implementation of global and regional labelling, including:
- Core Data Sheets (CDS/CCDS)
- EU SmPCs, PILs, and Annexes
- US Prescribing Information (USPI), where applicable
About You
- Degree in a scientific or life sciences discipline
- Proven experience in regulatory labelling within pharma or biotech
- Strong knowledge of EU and UK labelling requirements (QRD, SmPC, PIL, Article 61/63)
- Exposure to global labelling environments (EU, US and/or international markets)
- Experience with labelling lifecycle management, artwork coordination, and implementation
- Familiarity with regulatory systems such as Veeva Vault (RIM / QualityDocs), EDMS, artwork tools, or similar
- Highly organised, detail-oriented, and comfortable working across multiple products and timelines
- Able to work collaboratively in a matrix, global environment
Nice to Have
- Experience responding to health authority labelling comments
- US labelling exposure (FDA annotations, supplements)
- Experience supporting launches or major labelling updates
- Previous experience in a global pharma or biotech organisation
Global Labelling Specialist in Portsmouth employer: Planet Pharma
Contact Detail:
Planet Pharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Labelling Specialist in Portsmouth
✨Tip Number 1
Network like a pro! Reach out to professionals in the biopharmaceutical field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Global Labelling Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU and UK labelling requirements. We recommend creating a cheat sheet of key regulations and examples from your experience to showcase your expertise during the interview.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you, and tailor your approach to each company’s culture and mission.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to show your genuine interest in the role.
We think you need these skills to ace Global Labelling Specialist in Portsmouth
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Global Labelling Specialist role. Highlight your experience in regulatory labelling and any specific knowledge of EU and UK requirements. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your skills can contribute to patient safety and compliance. Keep it concise but impactful – we love a good story!
Showcase Relevant Experience: When filling out your application, be sure to showcase any relevant experience you have with labelling lifecycle management and artwork coordination. We’re keen on seeing how you've navigated similar challenges in your previous roles.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about us and what we do!
How to prepare for a job interview at Planet Pharma
✨Know Your Labelling Regulations
Make sure you brush up on your knowledge of EU and UK labelling requirements, especially QRD, SmPC, and PIL. Being able to discuss these regulations confidently will show that you're well-prepared and understand the core responsibilities of the role.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience in regulatory labelling and lifecycle management. Discuss any challenges you faced and how you overcame them, particularly in a global context, as this will demonstrate your problem-solving skills.
✨Familiarise Yourself with Tools
If you have experience with regulatory systems like Veeva Vault or EDMS, be ready to talk about it. If not, do a bit of research on these tools so you can speak intelligently about how they fit into the labelling process.
✨Collaborative Mindset
This role requires working cross-functionally, so be prepared to discuss how you've successfully collaborated with different teams in the past. Highlight your communication skills and ability to work in a matrix environment, as this is crucial for success in the position.
