GRA RA EU and International Specialist

at  IQVIA

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 GRA RA EU and International Specialist who can join an exciting working environment in a dynamic and international atmosphere.

RESPONSABILITIES:

• Under guidance of the regional Head, 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.
• Contributes to the development of processes and the preparation of Standard Operating Documents for Global Rare Disease RA.
• 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.

Please refer the Job description for details