Regulatory Affairs Post-approval Senior Officer

2 days ago

Athens, Attica, Greece DEMO AΒΕΕ Full time €60,000 - €80,000 per year

Regulatory Affairs Post-approval Senior Officer

DEMO AΒΕΕ

ΑΚΟΛΟΥΘΗΣΕ

Φαρμακευτικές & Κλάδος Υγείας

Προβολή 9 θέσεων

ΑθήναΤοποθεσία

Αθήνα

πριν 24 μέρες

Ημ. ανάρτησης

πριν 24 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 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.

Σχετικά tags

pharma industry

senior regulatory affairs

senior officer

regulatory

pharmamanufacturing

pharmaceutical

pharma

pharm

ra

pharmaceutical production

ΠΕΡΙΛΗΨΗ ΘΕΣΗΣ

Regulatory Affairs Post-approval Senior Officer

DEMO AΒΕΕ

ΑΚΟΛΟΥΘΗΣΕ

Αθήνα

πριν 24 μέρες

Με μεγάλη εμπειρία

Πλήρης απασχόληση

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