Regulatory Affairs Specialist

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Provide operational regulatory support to a pharmaceutical affiliate in Greece, with primary responsibility for the maintenance and lifecycle management of national Marketing Authorisations (MAs), particularly for an oncology product. The role also supports regulatory activities across several European distributor markets.

• →Manage the lifecycle of MAs and ensure regulatory compliance.
• →Prepare, submit, and track regulatory variations, renewals, and post-approval changes.
• →Support new Marketing Authorisation applications when required.
• →Review and maintain product information and regulatory documentation.
• →Approve local translations, labelling, packaging, and artwork materials.
• →Coordinate regulatory activities with affiliates, distributor markets, and global teams.
• →Partner with cross-functional teams and provide support for Quality/GDP activities when needed.

• Degree in Pharmacy, Life Sciences, Biology, Chemistry, or a related scientific field.
• At least 3 years of Regulatory Affairs experience in the pharmaceutical industry.
• Experience with submissions, variations, renewals, and MA lifecycle management.
• Strong knowledge of European pharmaceutical regulations and regulatory processes.
• Understanding of product information, labelling, and regulatory documentation requirements.
• Strong organizational, project management, and stakeholder communication skills.
• Fluent Greek and English
• Oncology, GDP, or Quality Assurance experience is a plus.