Global Regulatory Affairs Manager-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

Global Regulatory Affairs Manager-Maternity Cover IQVIA Italia•Emilia-Romagna, Italy

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.

Purpose:

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.

Supports development and/or execution of Global Regulatory Strategy to support the TPP.

Ensures alignment of TPP to core product labelling for development/lifecycle management for the assigned region(s).

Main Responsibilities:

• 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. authoring, leading and moderating preparation meetings;
• 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;
• Ensures that regulatory submission timelines are aligned with program level and company objectives;
• Contributes to content and reviews for regulated documents;
• 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;
• Accountable to support the GRL on updates to the Affiliates and interactions with IMDD and partners.

Experience Required:

• Around 3-4 years' experience in International Regulatory Affairs;
• Experience in regulatory affairs within rare diseases is preferred.

Technical Skills:

• 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 ;

Soft Skills:

• Stress management;
• Time management;
• Planning and organizational skills;
• Strategic thinking.

Type of contract:

National Collective Labour Agreement: Chemical and Pharmaceutical Industry;

Contract Type: Fixed Term-temporary position covering maternity leave;

Salary Range or Gross Annual Salary: from 46.000€ to 57.000€ RAL.