July, 2nd

CMC Scientist Pre Approval

CMC PrA
PREV. JOB NEXT JOB

Role and Responsibilities

• 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 EU Regulatory Agencies
• Dossier customization as per client needs
• Maintenance of GAP analysis until first dossier approval
• Record commitments made during registration
• Overall customer support for any CMC queries received at pre-submission phase and only for DCPs/CPs/MRPs at post-submission phase as well

Experience & Qualification

• Post – graduate degree level in Pharmacy, Pharmacology, Chemistry, Biology or similar scientific disciplines
• At least 2 years’ relevant experience in CMC or Regulatory Affairs
• 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
• 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
Continuous training
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: cv@pharosgr.gr

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