Senior Regulatory Affairs Manager

7 days ago

Basingstoke Hampshire, United Kingdom Cpl Life Sciences Full time

Job Title: Senior Manager, Regulatory Labelling Location: UK, Fully Remote
Salary: Competitive Salary + Excellent Benefits
Employee Type: Permanent

As a Senior Manager, Regulatory Labelling, you will take leadership on everything related to Regulatory Labelling. This includes inputting from a regulatory labelling perspective on developing and established drug programs and being accountable for driving global labelling strategies. This is a challenging opportunity to demonstrate your knowledge in managing regulatory processes and supporting cross-functional teams with end-to-end labelling processes.

Be responsible for executing and effective quality control reviews and tracking (primarily) internally used labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (EU SmPC, EU PIL, etc) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents.
Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading/editing skills and compiling supportive documentation.
Support labeling inspection/audit readiness activities.
Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed.
Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control.
Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines.

University Degree in a scientific degree.
~ 5+ years of experience in drug development especially in labelling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
~ Electronic document management systems use and / or electronic submission experience
~ Regulatory Information Management System (RIMS), electronic document management system (EDMS). Ability to manage the review and approval of labeling in a document management system.
~ In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams
~ Fluent in English written and spoken

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