Regulatory Affairs Post-approval Senior Officer

3 days ago

Athens, Attica, Greece Demo S.A. Full time

At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Post-approval Senior 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
  • Assist and support the junior personnel of the team for the projects they have undertaken
  • Preparation of module 1 documentation for DCP, MRP, RUP and National applications in line with assigned timelines for out-licensing and in-licensing products in EU countries
  • Collect, prepare, compile regulatory documentation, for the product's lifecycle maintenance (administrative, quality, safety variations and renewal procedures).
  • 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 including CMC variation filling.

Requirements

  • BSc Degree in Chemistry, Biology or relevant field.
  • 2-4 years of experience in Regulatory Affairs / CMC within a Pharmaceutical organization.
  • Fluent in English and good MS Office skills
  • Good command of eCTD software and CESP platform.
  • Strong organization skills, multi-tasking and able to meet deadlines
  • Effective communication and relationship management
  • Knowledge of EU and global regulatory guidelines
  • 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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