ID EXISTS
POS 2969
Status 5
DJM 1

Junior Regulatory Affairs Manager

Beschreibung: For one of our Swiss Pharma clients we are looking for temporary support as: (Associate) Regulatory Affairs CMC Manager (M/F/D)
Tasks:
  • Author high-quality CMC documentation for Health Authority submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
  • Prepare CMC responses to health authority questions during development, registration and product lifecycle
  • Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
  • Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible
Qualifications:
  • Start: asap / Duration: until end of 2019 / Capacity: 40 h/week
  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
  • Knowledge of the drug development process desirable
  • Knowledge of regulations, guidelines for NCEs and product life cycle maintenance desirable.
  • Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously
  • Business Fluency in English
Bemerkungen: WANTED: 2x (Associate) Regulatory Affairs CMC Manager (M/F/D). Please contact +49 89 18 90 998 30 or maria.haushofer@k-recruiting.com Skills: CMC (Regulatory Affairs), English, Pharma, Regulatory Affairs
Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 7 months +
Einsatzort: Greater Basel, Switzerland
WhatsApp-Service: Mit WhatsApp zum nächsten Projekt!

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