CMC Scientist – Pre Approval

3 days ago

Athens, Attica, Greece PharOS Ltd Full time €40,000 - €80,000 per year

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 Responsibilities

  • Data evaluation for compliance with EU & ICH guidelines
  • Dossier compilation of Modules 2-5 in eCTD format
  • 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

Requirements

  • Post - graduate degree level in Pharmacy, Pharmacology, Chemistry, Biology or similar scientific disciplines
  • At least two (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 (including bonus based on performance)
  • Private Health & Medical Insurance including a 24/7 support Line
  • Daily free transportation from/to the Company's HQs to nearby public means of transportation
  • Canteen with discounted prices and daily cooked meals
  • Continuous training
  • Friendly and challenging working environment

PharOS 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.

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