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.

EXPERIENCE REQUIRED:

Around 3 years’ experience in Regulatory Affairs

EDUCATION:

Master’s degree

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

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.