Global Regulatory Affairs Specialist
3 settimane fa
Job Title: Global Regulatory Affairs Associate
Job Summary: We are seeking a highly skilled Global Regulatory Affairs Associate to join our team in Florence. 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 of scope.
Main Activities and Responsibilities:
- Plan and organize activities for preparing new product registration and maintenance of existing registration through variation procedures and renewals.
- Work 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.
- Prepare the master data package to be shared with local regulatory affairs contacts in order to proceed with customization, as necessary, and submission of the application to the competent Authority/ies.
- Apply existing working flows and Company procedures.
- Monitor and understand new RA regulations and guidelines for the area of responsibility.
Job Requirements:
- Bachelor Degree in a scientific environment, including but not limited to, Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, Chemistry is mandatory.
- 1 year of previous experience in the regulatory environment is preferred.
- Fluent in English, both written and oral.
- The candidates should be dynamic, proactive and willing-to-do person.
- The candidate should have excellent interpersonal, organizational and communication skills, capability in working in a team and good problem-solving attitude.
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