Regulatory Affairs

1 day ago

Athens, Attica, Greece DEMO AΒΕΕ Full time €25,000 - €40,000 per year

Regulatory Affairs (Pre-Approval) Supervisor

DEMO AΒΕΕ

ΑΚΟΛΟΥΘΗΣΕ

Φαρμακευτικές & Κλάδος Υγείας

Προβολή 11 θέσεων

ΑθήναΤοποθεσία

Αθήνα

πριν 2 μέρες

Ημ. ανάρτησης

πριν 2 μέρες

Με μεγάλη εμπειρίαΕπίπεδο εμπειρίας

Με μεγάλη εμπειρία

Πλήρης απασχόλησηΤύπος απασχόλησης

Πλήρης απασχόληση

Επιστημονικός ΚλάδοςΚατηγορία θέσης

Επιστημονικός Κλάδος

At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs (Pre-Approval) Supervisor 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
  • 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.
  • 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

Requirements

  • BSc Degree in Pharmacy, Biology or relevant field.
  • 5+ years of experience in Regulatory 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 EU 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.

Σχετικά tags

pharma industry

senior regulatory affairs

senior officer

regulatory

pharmamanufacturing

pharmaceutical

pharma

pharm

ra

pharmaceutical production

ΠΕΡΙΛΗΨΗ ΘΕΣΗΣ

Regulatory Affairs (Pre-Approval) Supervisor

DEMO AΒΕΕ

ΑΚΟΛΟΥΘΗΣΕ

Αθήνα

πριν 2 μέρες

Με μεγάλη εμπειρία

Πλήρης απασχόληση

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