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- Tasks: Join a global team to manage regulatory labeling for pharmaceutical products in the EU and US.
- Company: Work with a leading biopharmaceutical company dedicated to improving lives through innovative medicines.
- Benefits: Enjoy hybrid working options and competitive daily pay rates.
- Why this job: Make a real impact on product safety and compliance while collaborating with experts in the field.
- Qualifications: Bachelor's degree and experience in regulatory program management required; expertise in EU and US labeling is a plus.
- Other info: Must be eligible to work in the UK and may require a DBS check.
The predicted salary is between 70000 - 84000 £ per year.
CK Group are recruiting for a Regulatory Labelling Manager, to join a company in the Pharmaceutical industry, at their site based in Welwyn Garden City, on a contract basis for 12 months.
Salary:
PAYE £367.54 – £376.97 per day or £487.50 – £525 per day Umb/Ltd (outside of IR35).
Regulatory Labelling Manager Role:
- Contribute to the global product team in crafting and maintaining the company Core Data Sheet (CDS), core Patient Product Information (cPPI), and key local product labels for the EU and US throughout the lifecycle of pharmaceutical products and devices, ensuring compliance with labeling requirements.
- Apply critical thinking and effective data messaging in the creation and maintenance of regulatory labeling documents, ensuring clarity and accuracy in product information.
- Lead or contribute to company documents and responses to Health Authority requests related to product labeling, facilitating clear communication and compliance with regulatory standards.
- Guide the product team and country affiliates in the implementation of CDS updates to local labels, ensuring consistency and adherence to global regulatory requirements.
Your Background :
- Bachelor's degree with solid proven experience in current therapeutic area focus in Regulatory Program Management.
- Expertise with regulatory labelling and working on CCDS for EU and US.
- Understanding of Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP) principles and data integrity.
Company:
Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.
Location:
This role is based at our clients site in Welwyn Garden City, with hybrid working for 2/3 days onsite required per week.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 119 147 in all correspondence.
Please note:
This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
If this position isn't suitable but you are looking for a new role, or if you are interested in seeing what opportunities are out there, head over to our LinkedIn page (cka-group) and follow us to see our latest jobs and company news.
Regulatory Affairs Labelling Manager employer: CK Group
Contact Detail:
CK Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Labelling Manager
✨Tip Number 1
Familiarize yourself with the specific regulatory requirements for labeling in both the EU and US. Understanding the nuances of these regulations will not only help you in interviews but also demonstrate your expertise in the field.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who work in regulatory affairs. Engaging with others in the field can provide valuable insights and potentially lead to referrals for the position.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory practices by following relevant publications and attending webinars. This knowledge can set you apart as a candidate who is proactive and informed.
✨Tip Number 4
Prepare to discuss specific examples from your past experience where you successfully managed regulatory labeling projects. Highlighting your critical thinking and problem-solving skills will be crucial during the interview process.
We think you need these skills to ace Regulatory Affairs Labelling Manager
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory Labelling Manager position. Understand the key responsibilities and required qualifications, especially regarding regulatory labelling and compliance.
Tailor Your CV: Customize your CV to highlight relevant experience in regulatory affairs, particularly in crafting Core Data Sheets and Patient Product Information. Emphasize your expertise with EU and US regulations.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your critical thinking skills and experience in regulatory labelling. Mention specific examples of how you've contributed to compliance and clarity in product information.
Follow Application Instructions: When applying, ensure you include the job reference number (119 147) in your application. Double-check that all required documents are attached and that your application is submitted through our website.
How to prepare for a job interview at CK Group
✨Understand Regulatory Requirements
Make sure you have a solid grasp of the regulatory labeling requirements for both the EU and US. Familiarize yourself with the Core Data Sheet (CDS) and core Patient Product Information (cPPI) to demonstrate your expertise during the interview.
✨Showcase Your Critical Thinking Skills
Prepare examples that highlight your ability to apply critical thinking in creating and maintaining regulatory labeling documents. Be ready to discuss how you ensure clarity and accuracy in product information.
✨Communicate Effectively
Since the role involves leading or contributing to responses to Health Authority requests, practice articulating your thoughts clearly. Prepare to discuss how you facilitate communication and compliance with regulatory standards.
✨Highlight Your Experience
Be prepared to discuss your background in Regulatory Program Management and your experience with CCDS. Emphasize your understanding of Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP) principles to showcase your qualifications.
