Global Regulatory Affairs Specialist

ISS IQVIA CSMS GMBH; Milano; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading company is seeking a Global Regulatory Affairs Specialist for a dynamic environment in Milan. The role requires expertise in European and global regulatory strategy, with responsibilities including developing regulatory submissions and liaising with health authorities. Successful candidates will have a Master's degree and approximately 3 years of experience in Regulatory Affairs.

Servizi

Competitive salary package

Permanent contract

Chemical contract

Competenze

• Around 3 years' experience in Regulatory Affairs.
• Fluent in English.
• Understanding of LCM activities and ability to handle multiple projects.

Mansioni

• Develop and lead regulatory submission strategies.
• Serve as point of contact with health authorities.
• Ensure timelines meet project and company objectives.

Conoscenze

Team working

Stress management

Time management

Planning and organizational skills

Strategic thinking

Emerging understanding of clinical development

Data readiness & competitive intelligence

Formazione

Master's degree

Strumenti

Veeva Vault

Descrizione del lavoro

Our client,Chiesi Farmaceutici– one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of aGlobal Regulatory Affairs Specialist who can 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 years' experience in Regulatory Affairs

Education:

Master's degree

Languages:

English fluent

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:

• Team working
• Stress management
• Time management
• Planning and organizational skills
• Strategic thinking

We offer:

• Competitive salary package
• Permanent contract
• Chemical contract

IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. 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. The research is urgent and is intended for candidates of both sexes (L.903/77).

#LI-CES #LI-DNP

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com