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Chemistry, Manufacturing & Controls (CMC) Scientist – Post Approval από την εταιρεία PharOS Ltd

5 ημέρες για να κάνετε αίτηση
Πλήρης Απασχόληση
Αθήνα

Περιγραφή Θέσης

About PharOS
Developing Value, Supplying Success

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 85 professionals. Biologists, Chemists, Pharmacists, scientists 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 86 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 expanding its product pipeline and is currently recruiting, for CMC Scientist within the Chemistry Manufacturing & Controls department based in company’s Headquarters in Athens, Greece.

We are seeking for

                          Chemistry, Manufacturing & Controls (CMC) Scientist – Post Approval 

Role Description 
  • 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

Κωδικός αναφοράς

CMC) Scientist – Post Approval

Όμοιες Θέσεις

Formulation Development Scientist Αθήνα PharOS Ltd
REGULATORY AFFAIRS OFFICER Πικέρμι ELPEN Α.Ε.
Υπεύθυνος-η για το Τμήμα Διασφάλισης Ποιότητας Οινόφυτα Εταιρία Παραγωγής & Εμπορίας Καταναλωτικών Ειδών
Quality Assurance Officer Αθήνα Cana A.E.
Medical Writer Ilio (Nea Liossia) Integrated Scientific Solutions- InSciSol
Regulatory Compliance Officer Αθήνα Human Factor

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