Advanced Resource Managers are currently searching for a Regulatory Labelling Specialist for one of our client who are a small but growing Consultancy.
You will be involved with the following responsibilities within the role –
· Manage the labeling review and approval processes.
· Support the creation and maintenance of regulatory compliant documents.
· Working closely with the Medical Affairs team to provide medical relevance assessment and labeling guidance.
· Conducting Text comparison (originator, reference vs generic)
· Documenting and monitoring of all global and local changes for the assigned portfolio of brands/products
· Contribute to labeling process improvement initiatives
Skills/Experience needed
· Degree qualified
· 3+ years of labeling experience within the Pharma industry (Generics) or experience in Regulatory Affairs
· Understanding of labeling changes
· Solid knowledge of labeling guidelines and regulations
· Experience in documentation and archiving
· Experience with docuBridge and drugTrack is an advantage.
· Team player with good communication skills
If you are interested in this opportunity, please contact Vik Patel at ARM on