Regulatory Affairs Specialist

19 ore fa


San Miniato Basso, Toscana, Italia Manpowergroup A tempo pieno
Regulatory Affairs Associate Job Description

Talent Solution, part of Manpower Group, is seeking a motivated Regulatory Affairs Associate to join our Global Regulatory Affairs department. The successful candidate will be responsible for handling a specific portfolio of products, ensuring the obtainment of new registrations and/or the maintenance of existing ones in the Region in scope.

Main Activities and Responsibilities
  • Plan and organize activities for preparing new product registration and maintenance of existing registration 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 the preparation of regulatory applications related to new registrations and lifecycle management.
  • Prepare master data packages for sharing with local regulatory affairs contacts, and submit applications to competent authorities.
  • Monitor and understand new RA regulations and guidelines for the area of responsibility.
Job Requirements
  • A degree in a scientific environment, including Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, or Chemistry, is mandatory. A Master's degree or previous experience in the regulatory environment is preferred.
  • Fluent in English, both written and oral. The ideal candidate should be dynamic, proactive, and possess excellent interpersonal, organizational, and communication skills, with the ability to work in a team and demonstrate a good problem-solving attitude.


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