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.
- 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