POS 4242
Status 10

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/*)
K-RECRUITING Life Sciences Personalberatung - flip image
  • 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)
K-RECRUITING Life Sciences Personalberatung - box background image
  • 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
K-RECRUITING Life Sciences Personalberatung - parallax image
Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 12 months
Einsatzort: Basel, Switzerland and remote
WhatsApp-Service: Mit WhatsApp zum nächsten Projekt!

Bei uns sind Sie richtig. Nicht nur dank perfekt passender Projekte.


Was Sie als Consultant von uns erwarten können.


Weshalb sich eine Zusammenarbeit mit uns für Sie lohnt.


Jetzt registrieren und zukünftig passende Projekte direkt über WhatsApp erhalten.