February, 19th

CMC Scientist Pre – Approval

CMC_PA_0220
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Role and Responsibilities

Reports to CMC Supervisor, Senior Supervisor & Manager

  • Create and review product CMC relevant documentation in line with EMA and ICH guidelines intended for dossier compilation of Modules 2-5
  • Review, edit and create e-CTD CMC regulatory submissions
  • Compilation and monitoring of the progress of scientific responses to deficiencies raised by the regulatory agencies
  • Compilation of additional comparative in-vitro study reports for non-EU submissions and dossier customization as per client needs
  • Maintenance of GAP analysis until first dossier approval
  • Record commitments made during registration
  • Complete pre-audit checklists, organize on-line dossier audits and compile responses to clients’ audit comments for Modules 2-5, after the first dossier submission
  • Overall customer support for any CMC queries received

Experience & Qualification

  • Post – graduate degree level in Pharmacy, Pharmacology, Chemistry, Biology or similar scientific disciplines
  • At least 2 years’ relevant experience in CMC or Regulatory Affairs
  • Knowledge of ICH and EMA guidelines related to CMC
  • Knowledge of pharmaceutical technology related to oral solid dosage forms, oral solutions and injectable presentations
  • Excellent English oral communication and scientific writing skills
  • Strong organizational and project management skills
  • Detail orientation
  • Effective communication both internally and externally

PharOS Ltd Offers

Competitive remuneration package
Private medical scheme
Continuous training
Friendly and challenging working environment

Please apply for this position by forwarding your CV in English to: PharOS Ltd, Lesvou Str. (end), Thesi Loggos, Industrial Zone | 14452, Metamorfossi Attikis, Greece, via e-mail at: cv@pharosgr.gr

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