ID EXISTS
POS 4242
Status 10
DJM 1

Regulatory Affairs Associate for Biologics

Beschreibung: For one of our Swiss Pharma clients we are looking for temporary support as: Regulatory Affairs Associate for Biologics (M/F/*)
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Tasks:
  • Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies
  • Author CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle
  • 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
  • Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
  • Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned
  • Establish and maintain sound working relationships with partners and customers
  • Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions)
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Qualifications:
  • Start: asap // Duration: 12 months // Capacity: Full-time
  • Bachelor's Degree in Biology (eg. Neurology, Immunoligy), Biotechnology or Biochemistry
  • 1-2 years experience in Regulatory Affairs
  • Knowledge of the drug development process
  • Ability to critically evaluate data from a broad range of scientific disciplines
  • Knowledge of regulations, guidelines for New Chemical Entities (NCEs)
  • Experience in product life cycle maintenance
  • Business fluency in English
Bemerkungen: Skills: Associate, Biologist / Molecular Biologist, English, Pharma, Regulatory Affairs
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Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 12 months
Einsatzort: Basel, Switzerland and remote
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