GRA RA EU and International Specialist

• 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.

• 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

IQVIA