On behalf of our Client, Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world with more than 80 years of experience in the pharmaceutical and biotechnology industry, IQVIA is looking for a Global Rare Disease Regulatory Affairs Specialist EU∫ to join an exciting working environment in a dynamic and international atmosphere.
Main regulatory responsibilities:
Under guidance of the manager, prepares, compiles, and maintains regulatory documents to support a broad range of submissions to regional regulatory authorities within a given timeline;
In collaboration with consultants, partners and affiliates, plans, coordinates, and manages regulatory submissions to regional agencies throughout the life cycle of Global Rare Disease products;
Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., makes recommendations for improvement and ensures adequacy for submission;
Upon request of the manager, provides regulatory guidance to colleagues from other functional areas;
Prepares responses to questions and/or information requests from regulatory agencies within the timeframes specified;
Liaises with internal customers, and external customers (e.g., staff at the contract manufacturing organizations, partners, affiliates, and contract research organizations) to request and obtain data relevant to submissions;
Uses data management systems to track regulatory information pertaining to planned activities and life-cycle management of products.
Requirements:
2-3 years experience in regulatory affairs in EU or INT or both at corporate level in a multinational company;
Experience and knowledge in the life cycle management of regulatory filing;
Ability to work under supervision in the preparation of high-quality submissions and submission documents;
Strong attention to details and quality of documents and processes;
Well-developed written and oral communication and listening skills;
Well-developed time management skills
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