Global Regulatory Affairs Specialist

Our clientChiesi 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 extraEU 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 & EXTRAEU).
• 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:

Masters 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 extraEU 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 IQVIAs Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).

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