Regulatory Affairs CMC Senior Officer

2 days ago

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

DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, is currently looking for a talented Regulatory Affairs CMC Senior Officer to join our team in Athens (Kryoneri). This position reports directly to the Regulatory Affairs CMC Manager.

Main duties and responsibilities:

  • Understanding of Regulatory strategy and documentation requirements
  • Act as responsible Regulatory Team member for assigned regulatory projects
  • Prepare, review, and maintain CMC documentation for regulatory submissions in Europe and rest of the world (ROW)  ensuring compliance with current GMP, ICH, and other relevant regulatory guidelines.
  • Prepare and coordinate responses to Deficiency Letters (DLs) and other CMC-related regulatory queries in collaboration with cross-functional teams.
  • Liaise with with R&D, QA, Regulatory Affairs, and Manufacturing teams to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration
  • Liaise with external Regulatory authorities as required
  • Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products


Requirements
  • BSc Degree in Chemistry, Pharmacy,  Biology or relevant field.
  • More than 3 years of experience in Regulatory Affairs / CMC within a Pharmaceutical organization
  • Knowledge of CMC and global regulatory guidelines
  • Fluency in English and good use of 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 remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.

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