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.
RESPONSIBILITIES:
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.
PROFILE:
Experience and knowledge in the life cycle management of regulatory filing.
2-year experience in regulatory affairs in EU or INT or both at corporate level in a multinational company.
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 and demonstrated ability to manage complex assignments.
Well-developed analytical and problem-solving skills.
Ability to work independently and as part of a team.
English level from advanced to fluency.
TYPE OF CONTRACT:
Maternity leave
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.
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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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