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RegCMC Associate Manager Job in Basel Switzerland

  • Advanced degree in pharmacy, biochemistry, biotechnology or equivalent
  • Working knowledge of biotechnology, analytics, pharmaceutical technology or drug development processes
  • Knowledge of regulations and guidelines for NCEs and product life cycle maintenance
  • Work experience in international project teams along with excellent communication and negotiation skills
  • Languages: fluent English both written and spoken
Your tasks:
  • Authoring high-quality CMC documentation with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, and e-publishing throughout project life cycle as an actively participant of a global team
  • Keeping knowledge up to date with regard to regulatory guidelines and new technical trends
  • Identifying required documentation for global submissions and negotiate the delivery of approved technical source documents
  • Supporting the general department such as DRAGON support, annual and product renewal writing, source documentation and other database entry activities
Send resume to soor@jobs-n-jobs.com
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