Regulatory Labeling Expert

22-04-2024
Job Type
Contract
Emp Type
Full Time
Functional Expertise
Regulatory Affairs
Salary Type
Hourly

Job Description

The labeling contractor will play a key role in providing regulatory expertise and guidance for successful development and implementation of global regulatory labeling strategy and documentation for the client's late stage and commercial programmes. 

JOB RESPONSIBILITIES

  • Create and update labeling content for assigned programs of marketed product in EU and international markets (coordinate for implementation of commercial labeling updates; drafting of new product branding, variations).
  • Develop project timelines and manage labeling projects from initiation to completion.
  • Leadership within Label Group and internal review and approval process of labeling documents.
  • Ensure labeling is compliant with local country regulations and guidances.
  • Author or collaborate with regulatory colleagues on regulatory submissions of labeling documents (package inserts, container labeling artwork).
  • Support International Regulatory Affairs colleagues when responding to local health authority queries about product labeling.
  • Manage labeling archive and internal trackers.

QUALIFICATIONS

  • Bachelors or advanced degree in a scientific discipline.
  • 8-10 years of regulatory labeling experience in the biopharmaceutical industry.
  • Experience with writing, developing, maintaining product labeling in EU, US and ROW experience 
  • Experience leading/driving Regulatory Affairs Labeling strategy and operational activities 
  • Global promotional review experience is desirable 
  • Required onsite in Switzerland
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Consultant