Regulatory Affairs Officer

DEMO S.A.

Athens, Greece

Full time Job

Jun 16

This job is no longer accepting applications.

Regulatory Affairs Officer


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 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
  • 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.

 

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.
  • 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.

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DEMO S.A.

DEMO S.A. Pharmaceutical Industry is an industrial and commercial organization, active in the development, production and sales of pharmaceutical prod...

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