Regulatory Affairs Manager – Greece, Cyprus & Malta

About the role

Takeda is seeking a Regulatory Affairs Manager to oversee the regulatory lifecycle of its product portfolio across Greece, Cyprus, and Malta. You will serve as the primary liaison with local Health Authorities and Global Regulatory Affairs, ensuring timely registrations, renewals, and compliance with labeling and documentation requirements.

Key responsibilities

• Lead new product registrations, renewals, variations, PSUR/PBRER submissions, and national phases of European procedures.
• Coordinate implementation of global dossier updates through change‑control processes.
• Maintain compliance of product information, labeling, artworks, and mock‑ups with EU, local, and global regulations.
• Prepare, review, approve, and distribute local regulatory translations and affiliate feedback.
• Build and sustain effective relationships with local Health Authorities.
• Support regulatory compliance during audits and inspections, identifying risks and improvement opportunities.
• Provide regulatory expertise to cross‑functional teams, including MLR reviews and product launch support.

Required profile

• Bachelor’s degree in Life Sciences or a related scientific discipline.
• Minimum of 3 years’ experience in Regulatory Affairs within a multinational pharmaceutical environment.
• Strong knowledge of EU and local regulatory requirements, lifecycle management, and marketing‑authorization procedures.
• Experience reviewing promotional/medical material against local legislation.
• Proven ability to interact with Health Authorities and manage multi‑product submissions.
• Fluent written and spoken Greek and English.

Required skills