Regulatory Affairs Specialist

1 mese fa

Parma, Emilia-Romagna, Italia IQVIA A tempo pieno
Job Title: GRA RA EU and International Specialist

Our client, Chiesi Farmaceutici, a leading pharmaceutical company, is seeking a highly skilled GRA RA EU and International Specialist to join their team. This exciting opportunity is part of their expansion plans, and they have entrusted IQVIA with the recruitment process.

Responsibilities:
  • Under the guidance of the regional Head, prepare, compile, and maintain regulatory documents to support submissions to regional regulatory authorities within a given timeline.
  • Collaborate with consultants, partners, and affiliates to plan, coordinate, and manage regulatory submissions to regional agencies throughout the life cycle of Global Rare Disease products.
  • Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., and make recommendations for improvement to ensure adequacy for submission.
  • Contribute to the development of processes and the preparation of Standard Operating Documents for Global Rare Disease RA.
  • Provide regulatory guidance to colleagues from other functional areas upon request of the manager.
  • Prepare responses to questions and/or information requests from regulatory agencies within specified timeframes.
  • Liaise with internal and external customers to request and obtain data relevant to submissions.
  • Use data management systems to track regulatory information pertaining to planned activities and life-cycle management of products.
Requirements:
  • Experience and knowledge in 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.
Contract Type:

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 (DL196/2003) - 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).

#LICES

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