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Regulatory Affairs CMC Supervisor

  • DEMO ABEΕ
  • Αθήνα
  • 23/2/2021

Στοιχεία αγγελίας

Σχέση απασχόλησης - Πλήρης ΑπασχόλησηΕλάχιστη Απαιτούμενη Εκπαίδευση - ΑΕΙΑπαιτούμενη Προϋπηρεσία - Τουλάχιστον 5 έτος/ηΚατηγορίες - Νομικό Τμήμα, Επιστήμες, Επαγγέλματα Υγείας

Περιγραφή

DEMO S.A. Pharmaceutical Industry is an industrial and commercial organization, active in the development, production and sales of pharmaceutical products. The company’s manufacturing plant in Krioneri of Attica, is the largest in Southeast Europe and one of the world’s largest, with state of art facilities of 57,000 m2, including a hi- tech Quality Control Laboratory of 1,600 m2.

DEMO S.A. is one of the major pharmaceutical manufacturers in Greece with a strong presence in hospital market, ranking first among all Greek pharmaceutical companies in terms of units sold. Our product portfolio includes injectable generic pharmaceutical formulations from several therapeutic categories: Injectable products of all forms such us Liquid injectables in glass ampoules, vials & bottles, sterile powders and freeze – dried formulations, Lyophilised products, Emulsions, Penems, Penicillins, Cephalosporins.

DEMO S.A. has faithfully served its export orientation over the last years, with its sales network expanding to Europe, Asia, Africa, Middle East, South America and Oceania. The company exports 82,4% of its annual production and is rapidly expanding its range of products to international markets. Our company is a registered supplier of the United Nations, UNICEF, World Health Organization, MSF and the International Red Cross. With 2,300 approved products in 85 countries worldwide and 970 employees, DEMO aims to reliably meet the needs of the market in Greece and internationally. Our cutting edge production facilities allow us to offer our partners services such as: • Worldwide distribution opportunities • Out-licensing services • Contract manufacturing operations.

In this dynamic and fast growing environment we are looking for a high caliber RA CMC Supervisor:            

Regulatory Affairs CMC Supervisor

Main duties and responsibilities:


  • Understanding of Regulatory strategy and documentation requirements
  • Act as responsible Regulatory Team member for assigned regulatory projects
  • Overall regulatory documentation for DCP, MRP and National applications in line with assigned timelines
  • Coach, guide and review deliverables of Regulatory Affairs Officers and Associates.
  • Liaise with external Regulatory authorities as required.
  • Ensure policies and procedures are properly understood, evaluated and carried out. Make sure modifications are investigated if necessary.
  • Preparation of submissions including CMC variation filling.
  • Liaise with various departments to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration
  • Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products
  • Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities



Experience, skills and qualifications required:

  • BSc Degree in Chemistry, Biology or relevant field.
  • 5+ years of experience in CMC within a Pharmaceutical organization.
  • Strong organization skills, multi-tasking and able to meet deadlines
  • Effective communication and relationship management
  • Knowledge of CMC and global regulatory guidelines
  • Fluent in English and good MS Office skills
  • Ability to work under pressure, resilience

 


The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.

All applications will be considered as strictly confidential. Please send your CV @ Reference code: CMC 02/21