- 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
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GRA RA EU and International Specialist - Parma, Italia - IQVIA
Descrizione
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:
PROFILE:
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. Please enter the authorization for the processing of personal data (DL196/ General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA's Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).
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