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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs within the pharmaceutical industry, focusing on Marketing Authorisation lifecycle management, compliance with European regulations, and effective communication with cross-functional teams. Proficient in managing submissions, variations, and renewals while ensuring product information accuracy.
Highest-signal resume keywords
Regulatory Affairs ExperienceMarketing Authorisation Lifecycle ManagementEuropean Pharmaceutical Regulations KnowledgeFluent Greek and EnglishProject Management Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory SubmissionsVariations ManagementRenewals ManagementOncology Product KnowledgeRegulatory ComplianceProduct Information ReviewLabelling RequirementsRegulatory DocumentationQuality AssuranceGood Distribution Practice (GDP)
Soft Skills
Organizational SkillsStakeholder CommunicationProject Management
Industry Keywords
Pharmaceutical IndustryMarketing AuthorisationsRegulatory ActivitiesCross-Functional CollaborationEuropean Distributor Markets
About the role
Key responsibilities & impact- Provide operational regulatory support to a pharmaceutical affiliate in Greece
- Maintain and manage the lifecycle of national Marketing Authorisations, particularly for an oncology product
- Support regulatory activities across several European distributor markets
- Manage Marketing Authorisation lifecycle 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 support Quality/GDP activities when needed
Requirements
What you’ll need- 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 Marketing Authorisation 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
Benefits
Comp & perks- Opportunity to work at Excelya, a mid-size CRO and one-stop healthcare provider
- Diverse projects across full-service, functional service provider, and consulting services
- Collaboration with preeminent experts
- Employee experience focused on natural talents, professional growth, and potential development
- Inclusive, collaborative environment
- Opportunity to contribute to scientific, operational, and human knowledge and improve the patient journey