Senior Regulatory Affairs Manager

vor 19 Stunden

Deutschland Cpl Life Sciences Vollzeit

Job Title: Senior Manager, Regulatory Labelling Location: Germany, 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. Support end-to-end labelling processes including driving labelling strategies for both development programs and established drugs and oversee all operational labelling activities.
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.
Act as operational expert for the Global Labeling tracking in RIMs, ensure development and maintenance of templates, collaboration features and system upgrades.
Support labeling inspection/audit readiness activities.
Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets.
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. Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines.

5+ years of experience in drug development especially in labelling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
~ Fluent in English written and spoken

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