On behalf of our Client, Chiesi Farmaceutici , one of the top 50 pharmaceutical companies in the world with more than 80 years of experience in the pharmaceutical and biotechnology industry, IQVIA is looking for a Global Regulatory Affairs Manager (fixed-term maternity cover) to join an exciting working environment in a dynamic and international atmosphere. As core member of the GRT and strategic partner of the GRL, leverages their regulatory expertise to contribute to the definition and drive the execution of aligned EU, extra-EU and/or global regulatory strategy working flexibly within and across regions to ensure the delivery of business objectives. Ensures alignment of TPP to core product labelling for development/lifecycle management for the assigned region(s).

May serve as a regional/local regulatory lead and point of contact both internally and with Health Authorities

- May contribute (independently or with GRL guidance) to the development of global HA interaction strategy in collaboration with GRT
- Accountable for developing, independently or with GRL guidance, the Health Authority engagement and interaction plans for their assigned products incl. Accountable for complete and accurate communication/interaction (including tracking) with the relevant HAs for the projects/products in their remit
- Leads, independently or with GRL guidance, regulatory sub team to ensure NDA/MAA/Extensions/Variations filings meet the project timelines, develop core global dossier, and collaborates with other GRT members as appropriate
- Supports operational and compliance activities for assigned deliverables,



HA contact report (EU & EXTRA-EU)
- Supports GMP, GCP, and GPV inspections from health authorities
- Accountable to provide updates on project and submissions status at GRT meetings;

Experience Required: Around 3-4 years' experience in International Regulatory Affairs;

Experience in regulatory affairs within rare diseases is preferred. Master's degree

- Languages: ~ English fluent
- Emerging understanding of clinical development of drugs and/or novel biologics products
- 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
- Stress management
- Time management
- Planning and organizational skills
- Type of contract: Contract Type: Fixed Term-temporary position covering maternity leave;

Salary Range or Gross Annual Salary: from 46.000€ to 57.000€ RAL. The salary range is defined based on experience, skills, and internal equity criteria. We are committed to fair and equal pay practices, in line with applicable pay transparency regulations (EU Directive 2023/970).

IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA’s Clients.

📌 Global Regulatory Affairs Manager-Maternity Cover (Emilia-Romagna)
🏢 IQVIA Italia
📍 Emilia-Romagna