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Regulatory Affairs Specialist

2 mesi fa

Firenze, Italia ManpowerGroup A tempo pieno
Job Title: Global Regulatory Affairs Associate

Talent Solution, part of Manpower Group, is currently recruiting a motivated Regulatory Affairs Associate for an important pharmaceutical client based in Florence.

Main Responsibilities:
  • Plan and organize activities for preparing new product registration and maintenance of existing registrations through variation procedures and renewals.
  • Collaborate with technical internal functions, such as Quality Assurance, Medical-marketing, Clinical Sciences, and Pharmacovigilance, as well as local regulatory teams or external partners for regulatory application preparation.
  • Prepare master data packages for customization and submission to competent authorities.
  • Apply existing working flows and company procedures.
  • Monitor and understand new RA regulations and guidelines for the area of responsibility.
Requirements:
  • Degree in a scientific environment, including Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, or Chemistry.
  • Master or previous experience in the regulatory environment is preferred.
  • Fluent in English, both written and oral.
  • Dynamic, proactive, and excellent interpersonal, organizational, and communication skills.