Regulatory Affairs Intern: Dossiers, Lifecycle & Compliance

Accord Healthcare; Milano; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

Accord Healthcare in Milano is seeking an entry to mid-level Regulatory Affairs professional to support dossier preparation and registration activities. The role involves maintaining product life-cycle, coordinating with local authorities, and ensuring compliance for launches and marketing materials from a regulatory perspective.

The candidate should have 6–12 months or more of RA experience, knowledge of pharmaceutical law, and an understanding of registration and reimbursement procedures.

Competenze

• Experience in regulatory affairs or internship in pharma is required.
• Knowledge of pharmaceutical law and doc requirements is essential.
• Understanding of registration and reimbursement procedures is expected.
• Strong analytical skills and well organized with flexibility.

Mansioni

• Prepare dossiers and applications to register new products and maintain life-cycle.
• Prepare parallel import applications for national and central procedures.
• Support relationships with local regulatory authorities to achieve registrations.
• Submit Life Cycle Management changes and variations, renewals, and sunset clauses.
• Coordinate artwork revision, proofreading, approval and implementation.
• Collaborate with supply chain and marketing for regulatory approvals on launches.
• Maintain and coordinate local databases and product master data.
• Liaise with HQ RA to prioritize new procedures and changes.
• Support Tender Dept. with quality and regulatory documentation.

Conoscenze

Regulatory affairs

Analytical skills

Organization

MS Office (Excel)

English (B2)

Communication

Formazione

Bachelor in Pharmacy/Biotechnology/Chemistry

Master in Regulatory Affairs (plus)

Strumenti

MS Office

Excel

Descrizione del lavoro

Accord Healthcare in Milano is seeking an entry to mid-level Regulatory Affairs professional to support dossier preparation and registration activities. The role involves maintaining product life-cycle, coordinating with local authorities, and ensuring compliance for launches and marketing materials from a regulatory perspective.

The candidate should have 6–12 months or more of RA experience, knowledge of pharmaceutical law, and an understanding of registration and reimbursement procedures.