Regulatory Labelling Specialist

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