Head of Regulatory Affairs - Europe (Pre-Approval)

At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Head of Regulatory Affairs - Europe (Pre-Approval) to join our team. This position is based in Athens, Kryoneri.

Responsibilities

• Lead EU pre‑approval regulatory strategy and documentation requirements. https://outlook.office365.com/owa/?ItemID=AAMkAGZmNWQ3MTJhLWY1Y2UtNGM1YS1iMTk1LThmY2ZiNmI1MjNjMgBGAAAAAAAGAdcPnqZ8TZP0N%2fn2EQ2TBwDWPb%2fTT%2fNdQZGuTNoUvtFVAAAF4wKKAADWPb%2fTT%2fNdQZGuTNoUvtFVAAAF46p2AAA%3d&exvsurl=1&viewmodel=ReadMessageItem
• 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.https://outlook.office365.com/owa/?ItemID=AAMkAGZmNWQ3MTJhLWY1Y2UtNGM1YS1iMTk1LThmY2ZiNmI1MjNjMgBGAAAAAAAGAdcPnqZ8TZP0N%2fn2EQ2TBwDWPb%2fTT%2fNdQZGuTNoUvtFVAAAF4wKKAADWPb%2fTT%2fNdQZGuTNoUvtFVAAAF46p2AAA%3d&exvsurl=1&viewmodel=ReadMessageItem
• Act as primary liaison with EU Regulatory Authorities; coordinate responses to questions/deficiencies.https://outlook.office365.com/owa/?ItemID=AAMkAGZmNWQ3MTJhLWY1Y2UtNGM1YS1iMTk1LThmY2ZiNmI1MjNjMgBGAAAAAAAGAdcPnqZ8TZP0N%2fn2EQ2TBwDWPb%2fTT%2fNdQZGuTNoUvtFVAAAF4wKKAADWPb%2fTT%2fNdQZGuTNoUvtFVAAAF46p2AAA%3d&exvsurl=1&viewmodel=ReadMessageItem
• 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.
• 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

The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.