Head of Regulatory Affairs - Europe (Pre-Approval)

Head of Regulatory Affairs - Europe (Pre-Approval)

DEMO Pharmaceuticals

Athens, Greece

Responsibilities

• Lead EU pre‑approval regulatory strategy and documentation requirements.
• Own end‑to‑end dossiers for DCP/MRP/National submissions, ensuring quality and on‑time delivery.
• Line-manage/coach Regulatory Affairs Officers & Associates; review and sign off key deliverables.
• Act as primary liaison with EU Regulatory Authorities; coordinate responses to questions/deficiencies.
• Drive cross‑functional input for dossier compilation and maintain compliance for the registered portfolio.
• Understanding of Regulatory strategy and documentation requirements.
• Act as responsible Regulatory Team member for assigned regulatory projects.
• 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 ideally in similar position.
• 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.