Role and Responsibilities
Reports to CMC Supervisor, Senior Supervisor & Manager
• 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 post-approval submissions of Modules 2-5 and post submission phase of national procedures.
• Compilation and monitoring of the progress of scientific responses to deficiencies raised by the regulatory agencies pertaining to national submissions, 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 and at post-submission phase of national procedures
• Handling of pre audit checklists/tech packs, uploading of dossier for on-line review & compiling client audit responses.
• Handling of additional development activities needed mainly for non-EU submissions.
Experience & Qualification
• 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
• Strong organizational and project management skills
• Oriented to focus on detail
• Effective communication both internally and externally
PharOS Ltd Offers
Competitive remuneration package
Private medical scheme
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: firstname.lastname@example.org