Open to opportunities

Christina Photiou

@christinaphotiou

Message

Pharmacovigilance and Regulatory Affairs leader driving compliance and product launches.

Cyprus

Message

What I'm looking for

I seek roles where I can lead PhV/RA compliance, drive inspection readiness, manage vendors and projects, mentor teams, and contribute to product launches within a collaborative, quality-focused organisation.

I am a Pharmacovigilance and Regulatory Affairs manager with 12+ years' experience leading PhV, RA and compliance across more than 20 EU and global territories. I have a proven record in GVP audits, vendor management, inspection readiness with zero critical findings, managing new product launches, drafting SOPs and negotiating PVA/SDEAs.

I excel at stakeholder engagement, project and risk management, and building compliance frameworks that improve quality and meet regulatory expectations. I deliver measurable improvements through CAPA/QRM oversight, aRMM/DHCP local implementations, training programs and KPI-driven follow-up.

Experience

Work history, roles, and key accomplishments

Current

Pharmacovigilance and Regulatory Affairs Manager

Current

Genesis Pharma (Cyprus) Ltd

Dec 2019 - Present (5 years 10 months)

Led pharmacovigilance and regulatory compliance across 20+ EU and global territories, achieving 100% inspection readiness with zero critical findings and driving successful product launches and local RA interactions.

Pharmacovigilance Regulatory Affairs Vendor Management Risk Management RMP ARMM Implementation Stakeholder Engagement

Pharmacovigilance and Regulatory Affairs Officer

Genesis Pharma (Cyprus) Ltd

Jun 2018 - Dec 2019 (1 year 6 months)

Managed pharmacovigilance system and drug registrations, acted as LPPV for Biogen products, handled product variations and liaison with regulatory authorities to maintain compliance.

Regulatory Submissions SDEA Review GVP Compliance literature review DHCP Localisation

CAPA Coordinator / Quality Assurance Scientist

Remedica Ltd.

Feb 2017 - Jun 2018 (1 year 4 months)

Coordinated CAPA investigations and implemented quality and risk management processes using tools like FMEA and Ishikawa, ensuring timely closure and effectiveness of corrective actions.

CAPA Quality Assurance Root Cause Analysis KPI Tracking Training

Quality Representative / Pharmacovigilance Deputy LPPV

G.A. Stamatis Co. Ltd

Apr 2015 - Jan 2017 (1 year 9 months)

Maintained QMS and pharmacovigilance compliance for Roche and Sanofi Pasteur products, performed GDP audits, managed crisis responses (recalls, deviations) and delivered PV and H&S training.

GDP Audits Crisis Management RMM Localisation Training Health & Safety)Regulatory Compliance Health & Safety

Regulatory Affairs Submission Executive

United Europharma Ltd

Oct 2013 - Apr 2015 (1 year 6 months)

Prepared regulatory submissions and liaised with authorities for supplements, cosmetics, biocides and medical devices while implementing the company's ISO 9001 quality system.

Regulatory Submissions ISO 9001 Documentation Compliance Medical Devices

Education

Degrees, certifications, and relevant coursework

Middlesex University

Master of Science, Biomedical Science (Haematology and Transfusion)

2013 - 2014

Completed an MSc in Biomedical Science with a focus on haematology and transfusion, covering advanced laboratory techniques and clinical applications.