Stellenangebot : Senior Regulatory Affairs Manager (m / w / d)

Cpl Life Sciences; A distancia; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A leading life sciences company is looking for a Senior Manager, Regulatory Labelling to lead all aspects of global regulatory labelling strategies. Candidates should have over 5 years of experience in drug development, particularly in labelling and regulatory affairs, including quality control and collaboration across various teams. Strong English communication skills are essential. This is a permanent role that offers a fully remote work environment.

Formación

• 5+ years of experience in drug development especially in labelling and regulatory affairs.
• Familiarity with electronic document management systems and submissions.
• Proficiency in managing reviews and approvals within a document management system.

Responsabilidades

• Lead all aspects related to Regulatory Labelling.
• Drive global labelling strategies for drug programs.
• Conduct quality control on labeling documents to ensure regulatory compliance.
• Collaborate with Technical Operations for commercial distribution and submissions.
• Participate in continuous improvement of the labeling process.

Conocimientos

Leadership in Regulatory Labelling

Quality control reviews

Proofreading and editing

Collaboration across teams

Experience with electronic systems

Herramientas

Regulatory Information Management Systems (RIMS)

Electronic Document Management Systems (EDMS)

Descripción del empleo

Job Title

Senior Manager, Regulatory Labelling

Location

Spain, Fully Remote

Employee Type

Permanent

As a Senior Manager, Regulatory Labelling

Responsibilities

• You will take leadership on everything related to Regulatory Labelling.
• Inputting from a regulatory labelling perspective on developing and established drug programs and being accountable for driving global labelling strategies.
• 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.
• Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading / editing skills and compiling supportive documentation.
• Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets.
• 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.
• For labeling distribution, tracking and quality control.

Qualifications

• 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.
• Fluent in English written and spoken.