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Senior Global Regulatory Affairs Manager

vor 2 Wochen

Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

Job Overview:

CTC Resourcing Solutions is partnering with a global pharmaceutical leader to find an experienced Senior Global Labeling Manager. This contract role offers remote work within Switzerland, with occasional visits to Basel.

The ideal candidate will lead global labeling strategy and documentation, present proposed changes to stakeholders, research regulatory guidelines, and ensure global consistency in labeling changes with Country Organizations.

Responsibilities:

  • Lead Global Labeling Strategy: Develop and implement labeling strategies to meet regulatory requirements and company standards.
  • Presentation and Communication: Present proposed changes to stakeholders, including GLC, ELTF, RA Sub-teams, and SMTs.
  • Research and Analysis: Research regulatory guidelines, competitor labels, and clinical data to inform labeling decisions.
  • Collaboration and Coordination: Ensure global consistency in labeling changes with Country Organizations.
  • Document Development: Develop regulatory documents, respond to Health Authority queries, and support safety communications.
  • Review and Approval: Review and approve PSUR RA input and International Package Leaflets.
  • Mentorship and Process Improvement: Mentor junior labeling managers and drive process improvements.

Requirements:

  • Relevant Experience: 4–6 years in global labeling or 5+ years in regulatory affairs/pharma.
  • Education: Bachelor's or Master's in a science-related field (MD, PhD, PharmD preferred).
  • Languages: Fluent in English (additional languages a plus).
  • Skills: Strong regulatory knowledge, project management, leadership, and problem-solving.
  • Expertise: Medical terminology, drug safety, risk management, and business priorities.