Requirements: English
Company: IQVIA Italia
Region: italy, italy ,
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
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 IQVIAs Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).