November, 20th

Chemistry,Manufacturing & Controls (CMC) Scientist - Pre Approval

CMCSPrA
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PharOS is expanding its product pipeline and is currently recruiting, for Chemistry,Manufacturing & Controls (CMC) Scientist - Pre Approval within the operations of the CMC department based in company’s Headquarters in Athens, Greece.

Role Description

  • 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

The ideal candidate should have:

  • Education to a post-graduate degree level in Pharmacy, Pharmacology, Chemistry, Biology or similar scientific disciplines.
  • At least 2 years’ experience in CMC or Regulatory.
  • 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.
  • Very good organizational and project management skills.
  • Oriented to focus on detail.
  • Communicate effectively both internally and externally.

PharOS Ltd Offers

  • Competitive salary
  • Healthcare package
  • Continuous training on all aspects of CMC
  • Challenging working environment
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