November, 20th

Chemistry,Manufacturing & Controls (CMC) Scientist – Post Approval

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

Role Description

  • Lifecycle Management: Maintenance of marketing authorizations:
    • by submission of appropriate CMC variations for post-approval changes
    • by submission of renewals
    • by monitoring the fulfillment of the commitments made during registration
  • Create and review product CMC relevant documentation in line with ICH and EMA guidelines intended for Pharmaceutical Dossier post-approval submissions of Modules 2-5.
  • Compilation and monitoring of the progress of scientific responses to deficiencies raised by the regulatory agencies pertaining to post-approval variations, renewals and commitments.
  • Review and maintain the technical files of the products after their initial approval
  • Evaluate deviations to batch manufacturing documents, in order to identify any regulatory actions required for the marketed products.
  • Maintain the GAP analysis of each project.
  • Support clients for Modules 2-5 with regards to the products’ lifecycle.
  • Review, edit and create e-CTD CMC regulatory post-approval submissions.

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 on the lifecycle management of CMC submissions.
  • 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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