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RO
Roche
12d ago

Regulatory Labeling Manager(m/w/x)

Basel
Full-timeOn-siteExperienced

Description

You will drive global labeling strategies by crafting core product data and guiding affiliates through updates, ensuring the pharmaceutical portfolio remains compliant and patient-focused.

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Requirements

  • •Bachelor’s degree
  • •Three years of proven labeling experience
  • •Experience with CDS, EU, and US labels
  • •Experience in PD Regulatory Program Management
  • •Deep insight into strategic labeling
  • •Additional experience in market access (advantageous)
  • •Technical expertise in regulatory environment
  • •Strong project management skills
  • •Creative thinking for strategic proposals
  • •Knowledge sharing and team elevation
  • •Stakeholder relationship management and collaboration
  • •Ability to lead cross-functional matrix teams
  • •Strong influencing skills
  • •Adaptability and proactive learning mindset
  • •Understanding of GVP and GCP principles

Education

Bachelor's degree

Work Experience

3 years

Tasks

  • •Craft and maintain core labeling documents
  • •Manage EU and US local product labels
  • •Apply critical thinking to data messaging
  • •Ensure clarity in regulatory labeling documents
  • •Lead responses to Health Authority requests
  • •Guide affiliates on global label updates
  • •Partner with stakeholders on molecule portfolios
  • •Contribute to technical and healthcare initiatives
  • •Ensure compliance with corporate labeling policies
  • •Monitor industry trends and competitive landscapes
  • •Develop and update departmental operating procedures
  • •Optimize systems for content tracking and compliance

Tools & Technologies

CDS labelsEU labelsUS labelsGood Pharmacovigilance Practice (GVP)Good Clinical Practice (GCP)

Languages

English – Business Fluent

Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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