Regulatory Affairs - Europe (Pre-Approval) Supervisor

About the role

Demo S.A., one of the world's largest pharmaceutical manufacturers in injectable facilities, is looking for a Regulatory Affairs - Europe (Pre-Approval) Supervisor to join its team in Athens, Kryoneri. The role leads EU pre-approval regulatory strategy and documentation, owns end-to-end dossiers and manages the regulatory team.

Key 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 and coach Regulatory Affairs Officers and Associates, and review and sign off key deliverables.
• Act as primary liaison with EU Regulatory Authorities and coordinate responses to questions and deficiencies.
• Drive cross-functional input for dossier compilation and maintain compliance for the registered portfolio.
• Ensure policies and procedures are understood, evaluated and followed, and investigate necessary modifications.
• Liaise with departments to gather information for dossier submission and product registration, and support internal regulatory compliance activities.
• Compile and monitor scientific responses to regulatory authority deficiencies.

Required profile

• BSc degree in Pharmacy, Biology or a relevant field.
• 5+ years of regulatory experience in a pharmaceutical organization, ideally in a similar position.
• Fluent English and good MS Office skills.
• Strong organization, multitasking and deadline management, effective communication and relationship management.
• Knowledge of EU regulatory guidelines and ability to work under pressure.

What we offer

• Competitive salary and benefits.
• Continuous specialized training and career development.
• A friendly working environment.