Open to opportunities

Gresa Hoxha

@gresahoxha

I lead regulatory, pharmacovigilance, quality, and all other medical activities for medicinal products, gases, and devices across Kosovo.

Kosovo

Message

What I'm looking for

I'm seeking a primarily remote role with a European employer in regulatory affairs, pharmacovigilance, quality, medical activities, or compliance. I'm available for planned business travel across Europe, typically monthly or more often for audits, training, meetings, and key projects.

At SOL-K, part of SOL Group, I lead Medical Activities and serve as Qualified Person for medicinal-gas operations in Kosovo. I integrate regulatory, quality, and commercial priorities across medicinal products, medical gases, and medical devices.

I've managed marketing authorisations, variations, labelling, pricing, pharmacovigilance, GMP/GDP compliance, batch-related activities, audits, and authority submissions. My work includes coordination with the Kosovo Medicines Agency, European headquarters, distributors, hospitals, and technical teams.

Previously, I led Regulatory Affairs and Pharmacovigilance at Swixx BioPharma and Quality Assurance and Regulatory Affairs at Gentipharm Pharmaceuticals. I bring more than 10 years of experience supporting regulated healthcare products, including medical oxygen, nitrous oxide, and inhaled nitric oxide.

Experience

Work history, roles, and key accomplishments

Current

Medical Activities Director

Current

SOL-K LLC

Nov 2023 - Present (2 years 10 months)

Lead the Medical Activities function, integrating regulatory, quality, and commercial priorities. Serve as Qualified Person with QA/QC responsibilities for medicinal-gas operations.

Regulatory Affairs Quality Assurance Quality Control Pharmacovigilance GMP GDP Marketing Authorizations Audit Cross functional Leadership

Regulatory Affairs and Pharmacovigilance Manager

SwixxBioPharma

Dec 2018 - Jun 2023 (4 years 6 months)

Managed regulatory dossiers and lifecycle activities for marketing authorisations. Oversaw local pharmacovigilance responsibilities and maintained compliance with safety-reporting requirements.

Regulatory Affairs Pharmacovigilance Marketing Authorizations Compliance Submissions

Quality Assurance & Regulatory Affairs Manager

Gentipharm Pharmaceuticals

Jul 2016 - Dec 2018 (2 years 5 months)

Managed quality-assurance and regulatory-affairs activities, including batch-release oversight, audits, and regulatory submissions. Supported quality-system implementation and inspection readiness.

Quality Assurance Regulatory Affairs Batch Release Activities Audit SOPs Training