The Life Science Career Network 

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

Our client is looking a:

(Packaging) Operation Manager and Regulatory Affairs Support

for a 12 months-contract based in Basel area.

Main Responsibilities:

  • Project Support: Assist the Technical Project Leader in development, scale-up, validation, and manufacturing of drug substances from early development to commercialization.
  • Collaboration: Coordinate with internal CMC teams to ensure comprehensive technical development.
  • Procurement Management: Validate Requests for Proposals, complete purchase requisitions, and manage Purchase Orders (PO).
  • Supply Chain Oversight: Perform vendor selection for packaging partners and manage packaging validation activities. Ensure timely delivery of goods and services, manage payment schedules and invoice reconciliation, oversee the global supplier portfolio, and manage contracts.
  • Clinical Trials Support: Review and track regulatory documents for global clinical trials, participate in preparing Briefing Books for Health Authority meetings, and manage timelines and responses to quality questions from Health Authorities.
  • Regulatory Knowledge: Cooperate with CMC department to review the documentation.

Qualifications and Experience:

  • Swiss working/residency permit and/or Swiss/EU Citizenship required.
  • Master's Degree in Chemistry or similar.
  • Minimum 5 years of experience in the pharmaceutical industry (technical regulatory, R&D, product development, or manufacturing).
  • Knowledge of ICH guidelines (Quality) and basic understanding of Drug Substance/Product development, manufacturing processes, quality control, and regulatory environment.
  • Working knowledge of commercial packaging activities, validation and artwork creation.
  • Experience of working with and overseeing CMOs.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.