Global Regulatory Affairs Specialist

IQVIA LLC; Pavia; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a Global Regulatory Affairs Specialist to join a leading pharmaceutical client. The role involves strategic regulatory expertise, contributing to global regulatory strategy, and ensuring compliance with Health Authorities. Candidates should have around 3 years of relevant experience and a strong understanding of regulatory processes.

Servizi

Competitive salary package

Permanent contract

Chemical contract

Competenze

• Around 3 years' experience in Regulatory Affairs.
• Emerging understanding of clinical development of drugs.
• Ability to manage multiple projects.

Mansioni

• Serve as a regional regulatory lead and point of contact.
• Accountable for regulatory submission timelines.
• Develop Health Authority engagement and interaction plans.

Conoscenze

Understanding of clinical development

Ability to work in electronic document management systems

Multicultural sensitivity

Strumenti

Veeva Vault

Descrizione del lavoro

Global Regulatory Affairs Specialist page is loaded

Global Regulatory Affairs Specialist Apply locations Milan, Italy time type Full time posted on Posted Yesterday job requisition id R1482774

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 a Global 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

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

Soft Skills :

• 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

About Us

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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