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.
- 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