DEMO ΑΒΕΕ ΑΘΗΝΑ αναζητά Regulatory Affairs Officer

DEMO ΑΒΕΕ ΑΘΗΝΑ αναζητά Regulatory Affairs Officer

DEMO ΑΒΕΕ ΑΘΗΝΑ αναζητά Regulatory Affairs Officer

 

Regulatory Affairs Officer

On-site Athens, Attica, Greece Regulatory Affairs Full-time

Description

Main duties and responsibilities:

  • Understanding of Regulatory strategy and documentation requirements
  • Act as responsible Regulatory Team member for assigned regulatory projects
  • Prepare regulatory documentation for DCP, MRP and National applications in line with assigned timelines
  • 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.
  • 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
  • Preparation of submissions including CMC variation filling.

Requirements

Experience, skills and qualifications required:

  • BSc Degree in Chemistry, Biology or relevant field.
  • 1-2 years of experience in Regulatory Affairs / CMC within a Pharmaceutical organization.
  • Fluent in English and good MS Office skills
  • Strong organization skills, multi-tasking and able to meet deadlines
  • Effective communication and relationship management
  • Knowledge of CMC and global regulatory guidelines
  • Ability to work under pressure, resilience

Benefits

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

 

 

DEMO S.A. Pharmaceutical is an industrial and commercial organization, active in development, production and selling of pharmaceutical products. The manufacturing plant in Krioneri of Attica, is the largest in Southeast Europe and one of the world’s largest in generics sector, with state of the art facilities of 57,000 m2, including a hi- tech Quality Control Laboratory of 2.500 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: Liquid injectables in glass ampoules, vials & bottles, sterile powders and freeze – dried formulations, Lyophilised products, Emulsions, Penems, Penicillins, Cephalosporins, medical devices and food supplements.

Our new ambitious strategic plan of 2021 – 2025 includes investments inside and outside Attica.

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. We export 84% of our annual production and we are rapidly expanding our range of products to additional international markets. We are proud to be a registered supplier of the United Nations, UNICEF, World Health Organization, MSF and the International Red Cross. With more than 2.500 approved products in 85 countries worldwide and 970 employees, DEMO aims to reliably meet the needs of the market in Greece and globally.

DEMO S.A. implements a measurable corporate sustainability plan which is based on 4 pillars: Environment, Ethical Marketing, Employees and Society.

 

Ψάχνεις εργασία; Μπες στο ergasia.gr και βρες τον  επόμενο σταθμό της καριέρας σου!