Regulatory Affairs Specialist — Drive Product Approvals

Accord Healthcare; Italia; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

Accord Healthcare in Italy is seeking a Regulatory Affairs Specialist to support local regulatory workflows, prepare dossiers and applications for new registrations, and maintain product life-cycle management under supervision.

You will work with RA and QA teams, coordinate parallel import filings, liaise with regulatory authorities, manage Life Cycle Management changes, and ensure artwork and marketing materials meet regulatory standards.

Formación

• At least 6 months to 1 year of professional experience in a similar position or internship in a regulatory affairs department within a pharmaceutical company or a national competent authority.

Responsabilidades

• Prepare dossiers and applications to register new products and maintain existing product life-cycle.
• Prepare parallel import applications for national and central import procedures.
• Support relationships with local regulatory authorities to achieve positive outcomes for new product registrations, variations, renewals, notifications.
• Submit Life Cycle Management changes (variations, marketing status, sunset clause, renewals and line extensions).
• Coordinate artwork revision process, including requesting, proofreading, approval and implementation from a regulatory perspective.
• Collaborate with supply chain and marketing to ensure product launches and marketing materials comply with regulatory requirements.

Conocimientos

Regulatory knowledge

Regulatory liaison

Descripción del empleo

Accord Healthcare in Italy is seeking a Regulatory Affairs Specialist to support local regulatory workflows, prepare dossiers and applications for new registrations, and maintain product life-cycle management under supervision.

You will work with RA and QA teams, coordinate parallel import filings, liaise with regulatory authorities, manage Life Cycle Management changes, and ensure artwork and marketing materials meet regulatory standards.