Senior Technical Regulatory Affairs Manager

Idorsia Pharmaceuticals Ltd

Basel, Switzerland
On-site
Write and update ctd modules 2 and 3
Prepare briefing books for health authorities
Respond to health authority quality questions
Write, update, and keep track of the Module 2 (Quality Overall Summary) and the Module 3 (quality) of CTDs for global marketing applications

Job Summary

  • Write, update, and keep track of the Module 2 (Quality Overall Summary) and the Module 3 (quality) of CTDs for global marketing applications.
  • Prepare Briefing Books and supportive documentation for Health Authority meetings (pre-IND, pre-NDA, End of Phase II, Scientific Advice meetings).
  • Idorsia Pharmaceuticals Ltd is committed to a fair and transparent application process.

Matching Summary

Write, update, and keep track of the Module 2 (Quality Overall Summary) and the Module 3 (quality) of CTDs for global marketing applications.

Skills & Requirements

Must-have

  • Write and update CTD Modules 2 and 3
  • Prepare briefing books for health authorities
  • Respond to health authority quality questions
  • Manage regulatory impact of product changes
  • Track global submissions and approvals

Nice-to-have

  • Knowledge of other European languages
  • Foster respect, fairness, and equal opportunities

Key Requirements

  • University degree (Msc, PhD) in Pharmacy, Chemistry or biology
  • At least 5 years in technical/CMC regulatory field
  • Good MS Office, Veeva, DocuBridge skills
  • Advance knowledge of drug substance/product development

Work Rights

Not specified

Tailored Resume

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