Regulatory Affairs Labeling Consultant
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 labeling team, where you could join 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-oriented.
We are seeking experienced Regulatory Affairs Labelling professionals who 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 labeling in accordance with international regulatory requirements.
The Role
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
- Supporting/leading Labeling Working Committee Groups/ Labeling Review Committee
- Performing detailed gap analysis of Product Information against regulatory reference products, to determine the highest level of safety information
- Authoring updates using all relevant HA guidelines and the latest templates
- Preparing variation packages
- Undertaking literature reviews
- Post-approval activities
Requirements
Skills & Competencies:
- Strong background in regulatory affairs, with specific experience in labeling
- Knowledge of EU, US, and/or global regulatory requirements
- Experience with Document Management Systems
- Working knowledge of Veeva
- Excellent attention to detail and communication skills
- Life sciences degree or equivalent experience
- Experience in providing labeling support across study phases
How to Apply
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 behavior and promote equality of opportunity.
