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- Tasks: Join our team to manage global regulatory labelling projects and ensure compliance.
- Company: G&L Scientific is a leading consultancy in healthcare regulatory affairs, known for tailored solutions.
- Benefits: Enjoy hybrid working, a dynamic environment, and opportunities for professional growth.
- Why this job: Perfect for those who thrive in fast-paced settings and want to make an impact in healthcare.
- Qualifications: Strong regulatory affairs background, life sciences degree, and attention to detail required.
- Other info: We value diversity and promote an inclusive workplace for all applicants.
The predicted salary is between 36000 - 60000 £ per year.
Location: UK based, hybrid working. G&L office location is London Paddington, with occasional travel to client sites.
G&L is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance consultancy work – and we are rapidly growing! Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements are exceeded.
We now have some opportunities in our regulatory labelling team, where you could be joining our international team of experienced professionals who manage multiple global projects for a wide variety of clients – from giant pharma to niche biotechs. A day in the life of one of our consultants can be varied and unpredictable – this opportunity would be perfect for someone who thrives when busy, enjoys guiding clients through complex regulatory strategies and is completely solutions-orientated.
We are seeking experienced Regulatory Affairs Labelling professionals where you would be working in a matrix team of global consultants, with responsibilities to one or more of G&L’s clients. You would be responsible for ensuring accurate and compliant product labelling in accordance with international regulatory requirements.
Key Responsibilities:- Preparing and reviewing product labels, leaflets, and packaging for compliance with global regulations
- Collaborating with cross-functional teams including regulatory, medical, and commercial
- Supporting product submissions, updates, and lifecycle management activities
- Maintaining labelling documentation and change control records
- Safety signal assessments, creating and maintaining CCDS
- Experience in providing labelling support across study phases
- Supporting/leading Labelling Working committee groups/ Labelling review committee
- Performing detailed gap analysis of Product Information against regulatory reference products, to determine highest level of safety information
- Authoring updates using all relevant HA guidelines and latest templates
- Preparing variation packages
- Undertaking literature reviews
- Post-approval activities
- Strong background in regulatory affairs, with specific experience in labelling
- Knowledge of EU, US, and/or global regulatory requirements
- Experience of Document Management Systems
- Working knowledge of Veeva
- Excellent attention to detail and communication skills
- Life sciences degree or equivalent experience
If you would be interested in joining the team at G&L Scientific, please send your CV to talent @ gandlscientific.com today.
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.
Regulatory Affairs Labelling Consultant employer: G&L Scientific
Contact Detail:
G&L Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Labelling Consultant
✨Tip Number 1
Familiarise yourself with the latest EU and US regulatory requirements, as well as global standards. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience in labelling. Attend industry events or webinars to connect with potential colleagues and learn about current trends and challenges.
✨Tip Number 3
Showcase your attention to detail by preparing for discussions about specific labelling projects you've worked on. Be ready to discuss how you ensured compliance and overcame any challenges during those projects.
✨Tip Number 4
Research G&L Scientific's recent projects and clients. Understanding their approach and values will allow you to tailor your conversations and show how you can contribute to their success in regulatory affairs.
We think you need these skills to ace Regulatory Affairs Labelling Consultant
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory Affairs Labelling Consultant position. Tailor your application to highlight relevant experience in regulatory affairs and labelling.
Highlight Relevant Experience: In your CV and cover letter, emphasise your background in regulatory affairs, particularly any specific experience with product labelling and compliance with global regulations. Use concrete examples to demonstrate your expertise.
Showcase Attention to Detail: Given the importance of accuracy in this role, ensure that your application is free from errors. Pay close attention to formatting, grammar, and spelling in your CV and cover letter to reflect your meticulous nature.
Express Your Passion: In your cover letter, convey your enthusiasm for the role and the healthcare industry. Discuss why you are drawn to G&L Scientific and how your values align with their commitment to exceeding client expectations.
How to prepare for a job interview at G&L Scientific
✨Know Your Regulations
Familiarise yourself with the latest EU, US, and global regulatory requirements related to labelling. Being able to discuss specific regulations and how they apply to the role will demonstrate your expertise and preparedness.
✨Showcase Your Attention to Detail
Prepare examples that highlight your attention to detail, especially in preparing and reviewing product labels and documentation. This is crucial in regulatory affairs, so be ready to discuss how you've ensured compliance in past roles.
✨Collaborate Effectively
Since the role involves working with cross-functional teams, think of instances where you successfully collaborated with others. Be prepared to share how you navigated challenges and contributed to team success.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to regulatory affairs and labelling. This shows your genuine interest in the role and helps you understand how you can contribute to their goals.
