Global Regulatory Affairs Lead — Maternity Cover

Iqvia Italia; Emilia-Romagna; In loco; EUR 46.000 - 57.000; Tempo pieno

Descrizione del lavoro

IQVIA Italia seeks a Global Regulatory Affairs Manager (maternity cover) to lead regional regulatory activities and serve as a key interface with health authorities. You will drive global/regional regulatory strategies, align submissions, and support lifecycle management for assigned products across EU and extra-EU regions.

You will collaborate with the GRT and GRL, develop HA engagement plans, and contribute to regulated document content while ensuring timelines and inspections readiness.

Competenze

• 3-4 years' experience in International Regulatory Affairs.
• Experience in regulatory affairs within rare diseases is preferred.
• Emerging understanding of clinical development of drugs and/or novel biologics products.
• Understanding of LCM activities (strategy and executions EU/major extra-EU countries).
• Ability to work in electronic document management systems, such as Veeva Vault.
• Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred.
• Strong sensitivity for a multicultural/multinational environment.
• Data readiness & competitive intelligence.

Mansioni

• May serve as a regional/local regulatory lead and point of contact both internally and with Health Authorities.
• May contribute to the development of global HA interaction strategy in collaboration with GRT.
• Accountable for developing, independently or with GRL guidance, the Health Authority engagement plans for their assigned products.
• Accountable for complete and accurate communication with the relevant HAs for the projects in their remit.
• Leads regulatory sub team to ensure filings meet the project timelines and develops core global dossier.
• Ensures regulatory submission timelines are aligned with program objectives.
• Contributes to content and reviews for regulated documents.
• Supports GMP, GCP, and GPV inspections from health authorities.
• Provides updates on project and submissions status at GRT meetings.
• Supports the GRL on updates to the Affiliates and interactions with IMDD and partners.

Conoscenze

Regulatory affairs

Global regulation

Project coordination

Multicultural env

Strumenti

Veeva Vault

Descrizione del lavoro

IQVIA Italia seeks a Global Regulatory Affairs Manager (maternity cover) to lead regional regulatory activities and serve as a key interface with health authorities. You will drive global/regional regulatory strategies, align submissions, and support lifecycle management for assigned products across EU and extra-EU regions.

You will collaborate with the GRT and GRL, develop HA engagement plans, and contribute to regulated document content while ensuring timelines and inspections readiness.