11/12/2026 updated
Premium member
100 % availableSenior Regulatory Affairs Director | Pharmacovigilance & Global Regulatory Strategy
Strovolos, Cyprus
Only remote
DPhil, University of Sussex, 1998About me
Senior Regulatory Affairs professional with over 20 years of experience in the pharmaceuticals, leading global regulatory and CMC strategy across EU, MENA, ASEAN, and Africa. Expertise in pharmacovigilance, international regulatory submissions, IP, and cross-functional project leadership.
Strategic ManagementComplianceContract NegotiationPharmacovigilanceLabelingPharmaceuticalsProject Management Life CycleStakeholder ManagementStrategic ThinkingTechnical DocumentationProject ConsultingPharmaceutical RegulationsRegulatory Affairs
Regulatory Affairs Strategy
Over 20 years of expertise in developing and implementing global regulatory strategies across EU, MENA, ASEAN, and Africa, including CMC dossier management, labelling compliance, and marketing authorization submissions for pharmaceuticals.
Pharmacovigilance & Local QPPV
Extensive experience as Local QPPV and Pharmacovigilance Manager, serving as primary 24h contact for pharmacovigilance issues, ensuring compliance with EU legislation, managing safety agreements, and training company personnel locally and internationally.
Project & Cross-Functional Team Management
Proven track record in leading cross-functional projects, coordinating regulatory and commercial departments, managing budgets, and ensuring successful product launches across multiple markets.
IP & Compliance Management
Experience acting as primary contact with external lawyers on distribution agreements, in-licensing agreements, trademarks registration, patents evaluation, and GDPR implementation.
Quality Systems
Development and management of SOPs for promotional material, regulatory databases, and quality assurance processes in line with EU and international standards.
Strategic Planning
Direction of regulatory strategic plans supporting business development decisions and commercial viability throughout the product lifecycle.
Negotiating Skills
Skilled in negotiating with regulatory authorities, external stakeholders, and partners across multiple international markets.
Analytical Skills
Compilation of regulatory evaluation reports and analysis of guidelines and directives for EU and international markets to support strategic decision-making.
Regulatory Submissions for Medical Devices & Food Supplements
Management of notification submissions for Medical Devices and Food Supplements in compliance with applicable regulations.
Experience
Professional experience10+ years
Freelancer since2026
Languages
EnglishFluentGreekNative speaker
Project history
Providing strategic regulatory consultancy services for pharmaceuticals, medical devices, cosmetics, biocides and food supplements. Offering Pharmacovigilance support and Local QPPV services. Interim Regulatory Affairs leadership and project management. CMC and regulatory dossier management including labelling compliance and artwork review.
Directed the creation, implementation and development of the regulatory strategic plan for EU, Africa, MENA and ASEAN territories. Directed the CMC strategy reinforcing commercial viability at launch and throughout the product lifecycle. Provided regulatory guidance to Quality Affairs, Technical and Production departments. Managed notification submissions for Medical Devices and Food Supplements. Acted as primary contact with external lawyers on agreements and IP issues. Compiled regulatory evaluation reports for Business Development. Developed and managed department budget. Member of the GDPR company team.
Acted as primary 24h contact for Pharmacovigilance issues with external stakeholders and authorities. Worked with EU QPPV to ensure compliance with applicable legislation. Acted as primary contact for Medical Info and worked with the Medical Advisor. Trained company personnel locally and in non-EU regions. Primary contact for Safety Agreements for CMO and company branded business. Reviewed marketing brochures from the pharmacovigilance perspective.