Irene Dieronitou
Senior Regulatory Affairs Officer
Limassol
Summary
Senior Regulatory Affairs Officer managing product lifecycle management across CMC variations, renewals, and post-authorization maintenance. Coordinates submissions, variations, and renewals depending on company's strategic plan, maintains Marketing Authorization files, and coordinates with authorities while assisting internal and external stakeholders whenever requested to keep submissions accurate, compliant, and timely. Supports SOP updates, departmental reporting, and technical guidance across EU and non-EU requirements. Uses eCTD Manager.
Overview
2
2
Languages
6
6
Certifications
2027
2027
years of professional experience
Work History
Biologist
Sundial Co Ltd
Limassol
2018 - 2019
- Microbiologist
- Conducted microbial testing and analysis to ensure product safety and compliance with regulatory standards.
- Reduced contamination risk by maintaining a sterile laboratory environment and adhering to safety protocols.
- Ordered laboratory equipment and supplies.
- Conducted experiments related to cell culture.
- Analyzed and interpreted test results, providing critical insights for product safety.
Biology Teaching Assistant
Ministry of Culture and Tourism
Limassol, Limassol District
2017 - 2019
- Assisted teachers with classroom setup, material distribution, and end-of-lesson cleanup.
- Reinforced student understanding through one-on-one and small-group academic support.
- Monitored student participation during lessons and reported concerns to the lead teacher.
Senior Regulatory Affairs Officer
Remedica Ltd
Limassol
11.2025 - Current
- Maintain documentation accuracy while supporting Marketing Authorization files and stakeholder reporting.
- Review 5-10 regulatory files weekly for scientific accuracy, completeness, and alignment with applicable legislation.
- Provide regulatory guidance on CMC lifecycle activities, variations, renewals, and product maintenance across departments.
- Develop regulatory strategies for new Marketing Authorizations by assessing product data and registration requirements across territories.
- Communicate with Regulatory Authorities and external associates on MA submissions, evaluation progress, and approvals.
- Update departmental databases, coordinate cross-functional information requests, and support management with status updates and ad-hoc queries.
- Draft departmental SOPs, review process improvements, and support execution in line with established procedures and cGMP requirements.
Regulatory Affairs Officer
Remedica Ltd
Limassol, Limassol District
09.2021 - 10.2025
- Coordinated numerous in regulatory submissions across EU and non-EU requirements, internal procedures, and filing timelines.
- Managed numerous post-authorization activities per month, including lifecycle maintenance for pharmaceutical products.
- Prepared and assessed regulatory submission packages, maintaining compliant documentation for variations, renewals, and other lifecycle activities.
- Liaised with cross-functional teams to gather, review, and align scientific and technical inputs for lifecycle filings.
- Maintained regulatory records, databases, and submission timelines to support accurate tracking and timely follow-up.
- Used DMS and eCTD Manager to support submission management and controlled document handling across the lifecycle.
- Supported departmental knowledge sharing and regulatory reporting by supplying accurate status updates to senior management.
Junior Regulatory Affairs Officer
Remedica Ltd
Limassol, Limassol District
09.2019 - 09.2021
- Maintained regulatory records and tracking files across variations, renewals, and post-authorization activities.
- Supported regulatory submission packages by compiling pharmaceutical documentation and filing materials.
- Prepared regulatory documentation for pharmaceutical products, strengthening CTD compilation and submission readiness.
- Coordinated variations, renewals, and post-authorization activities while supporting marketing authorization maintenance.
- Tracked supporting documentation in RIMS and departmental databases while liaising with internal functions on compliance records.
Research Scientist
University of Cyprus
09.2016 - 05.2017
- Set up and run lab experiments.
- Gathered and performed data and statistical analysis.
- Prepared research report.
Education
Master of Business Administration - Business Administration and Management
Open University of Cyprus
Nicosia05-2026
Master of Science - Biomedical Sciences
University of Cyprus
Nicosia01-2016
Bachelor of Science - Biological Sciences
University of Cyprus
Nicosia01-2014
Skills
Product lifecycle management
CMC & post-authorization activities
Variations & renewals
Marketing authorization maintenance
Regulatory strategy development
Regulatory submissions & documentation
EU & non-EU regulatory requirements
Regulatory authority liaison
Certification
Pearson LCCI Level 2 Certificate in Book-keeping and Accounting, Distinction
Timeline
Senior Regulatory Affairs Officer
Remedica Ltd
11.2025 - Current
Regulatory Affairs Officer
Remedica Ltd
09.2021 - 10.2025
Junior Regulatory Affairs Officer
Remedica Ltd
09.2019 - 09.2021
Research Scientist
University of Cyprus
09.2016 - 05.2017
Master of Business Administration - Business Administration and Management
Open University of Cyprus
Master of Science - Biomedical Sciences
University of Cyprus
Bachelor of Science - Biological Sciences
University of Cyprus
Biologist
Sundial Co Ltd
2018 - 2019
Biology Teaching Assistant
Ministry of Culture and Tourism
2017 - 2019
Training
Microsoft Advanced Excel - ACE Training Ltd | 18-hour seminar, 2025
GDPR Compliance & Cybersecurity Awareness - Remedica Ltd, 2025
Impurity control in the Ph. Eur. - EDQM Council of Europe, 2024
Fundamentals of the CEP Procedure - EDQM, Council of Europe, 2024
Building successful CEP dossiers - EDQM, Council of Europe, 2024
The EDQM inspection programme - EDQM, Council of Europe, 2024
Control of impurities: CEP approach - EDQM, Council of Europe, 2024
Serialization Awareness Training - Remedica Ltd, 2020
Pharmacovigilance Training - Remedica Ltd, 2020
ADDITIONAL QUALIFICATIONS
- Pearson LCCI Level 3 Certificate in Accounting (Accounting Higher) - Gold Medallion, 1st place worldwide | 2019
- Pearson LCCI Level 2 Certificate in Book-keeping and Accounting – Distinction
- Pearson LCCI Level 1 Certificate in Book-keeping – Distinction
- Computerised Accounting – Powersoft 365
- Microsoft Office: Word, Excel, PowerPoint and Access - Excellent