CMC Scientist – Pre Approval

Founded in Athens in 2002, PharOS is a privately-owned pharmaceutical Company, developing and supplying generics value added products with a global portfolio. Our expertise covers all aspects of product development from API sourcing up to market release. We provide a broad portfolio of products and intellectual property to leading pharmaceutical companies.At PharOS, we have a high skilled workforce of more than 400 professionals. Biologists, Chemists, Pharmacists and Experts all focused on developing and placing in the market top quality generic and other value-added pharmaceuticals that improve the lives of patients to more than 98 countries. Our people are our core competitive advantage that helps us being one of the fastest growing pharmaceutical development companies in Europe. For PharOS our customers, are our partners! Our aim is to extend the lifecycle of the product, as our people are able to provide an exceptional level of customer service and support, based on their expertise and professionalism.PharOS is seeking for a CMC Scientist – Pre Approval as follows:Key ResponsibilitiesData evaluation for compliance with EU & ICH guidelinesDossier compilation of Modules 2-5 in eCTD formatCompilation and monitoring of the progress of scientific responses to deficiencies raised by the EU Regulatory AgenciesDossier customization as per client needsMaintenance of GAP analysis until first dossier approvalRecord commitments made during registrationOverall customer support for any CMC queries received at pre-submission phase and only for DCPs/CPs/MRPs at post-submission phase as wellRequirementsPost - graduate degree level in Pharmacy, Pharmacology, Chemistry, Biology or similar scientific disciplinesAt least two (2) years’ relevant experience in CMC or Regulatory AffairsKnowledge of ICH and EMA guidelines related to CMCKnowledge of pharmaceutical technology related to oral solid dosage forms, oral solutions and injectable presentationsExcellent English oral communication and scientific writing skillsStrong organizational and project management skillsOriented to focus on detailEffective communication both internally and externally PharOS Ltd OffersCompetitive remuneration package (including bonus based on performance)Private Health & Medical Insurance including a 24/7 support LineDaily free transportation from/to the Company’s HQs to nearby public means of transportationCanteen with discounted prices and daily cooked mealsContinuous trainingFriendly and challenging working environmentPharOS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, or any other basis protected by applicable law, and will not be discriminated against on the basis of disability.Please note that your resume and any personal information you have provided will be stored in our system for a period of one year, after which it will be deleted.