ID EXISTS
POS 3082
Status 9
DJM 1

2x Regulatory Affairs CMC (Associate) Manager

Beschreibung: For one of our Swiss Pharma clients we are looking for temporary support as: Regulatory Affairs CMC (Associate) Manager (M/F/*)
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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
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Qualifications:
  • Must-haves:
  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • Minimum 2 years of experience in Regulatory Affairs with CMC Module
  • Working knowledge with small molecules
  • Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously
  • Business Fluency in English
Bemerkungen: Skills: Associate, CMC (Regulatory Affairs), English, Pharma, Regulatory Affairs, Small Molecules
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Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 6 Months
Einsatzort: Basel Area, Switzerland
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