E-Regulatory Junior Specialist

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Irfa******

  • Italy 
  • Last Update: 01.01.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Italy
Country
Italy

Category


General Administrative

Description


Activities:

create, publish and submit eCTDs for all EU submissions (Global Regulatory Affairs and Global Pharmacovigilance) and Rest of the World submissions as needed;

support Global Regulatory Managers in the submission in electronic format (eCTD) of the documentation required for new products and life cycle management
finalize the eCTD for new Marketing Authorisation Applications and List of Questions during the regulatory assessment and lifecycle management of registered products.

Education: Degree in Chemical and Pharmaceutical Technology or Pharmacy. Master in Regulatory Affairs is a plus.

Experience: one year experience in Regulatory Affairs in pharmaceutical sector or at least 6-12 months of internships in the same filed

Technical Skills:

background in Regulatory Affairs,
knowledge on electronic aspects of Regulatory Affairs and proven skills related to IT systems
Excellent Proficiency with Microsoft Office and learning new computer software systems required.

Skills:

team working,
self-motivation
stress management,
responsible and accurate
critical thinking

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