Regulatory Affairs Specialist

4 settimane fa

Florence, Toscana, Italia ManpowerGroup A tempo pieno

Job Title: Regulatory Affairs Associate

Job Summary:

Talent Solutions, part of Manpower Group, is currently recruiting a motivated Regulatory Affairs Associate for an important pharmaceutical client based in Florence. The successful candidate will be responsible for handling a specific portfolio of products, guaranteeing the obtainment of new registrations and/or the maintenance of the existing ones in the Region in scope.

Main Activities and Responsibilities:

  • Planning and organizing activities for preparing new product registration and maintenance of the existing registration through variation procedures and renewals;
  • Working in cooperation with technical internal functions (such as Quality Assurance, Medical-marketing, Clinical Sciences, Pharmacovigilance), and local regulatory teams or external partners for the preparation of the regulatory application related to new registrations and lifecycle management;
  • Preparation of the master data package to be shared with the local regulatory affairs contacts in order to proceed with the customization, as necessary, and submission of the application to the competent Authority/ies;
  • Application of the existing working flows and Company procedures;
  • Monitoring and understanding of new RA regulations and guidelines for the area of responsibility.

Job Requirements:

  • Degree in scientific environment, including, but not limited to, Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, Chemistry, is mandatory;
  • A Master or a previous experience in the regulatory environment is preferred;
  • Fluent in English, both written and oral;

Key Skills:

  • Dynamic and proactive attitude;
  • Excellent interpersonal, organizational and communication skills;
  • Capability in working in a team and good problem-solving attitude.

Contract Type: Fixed term

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