Regulatory Affairs Pre-approval Officer

1 week ago

Athens, Attica, Greece Demo S.A. Full time €45,000 - €55,000 per year

At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Pre-approval Officer to join our team. This position is based in Athens, Kryoneri.

Responsibilities:

  • Understanding of Regulatory strategy and documentation requirements.
  • Act as responsible Regulatory Team member for assigned regulatory projects.
  • Preparation of module I documentation for DCP, MRP and National applications in line with assigned timelines.
  • 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.

  • 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.
  • Preparation of submissions.
Requirements
  • BSc Degree in Pharmacy, Biology or relevant field.
  • 1-2 years of experience in Regulatory Affairs
  • Fluent in English and good MS Office skills
  • Strong organization skills, multi-tasking and able to meet deadlines

  • Effective communication and relationship management

  • Ability to work under pressure, resilience

Benefits

The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.

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