Global Regulatory Affairs Specialist
2 settimane fa
ManpowerGroup is currently looking for a Global Regulatory Affairs Associate to join their 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.
Key Responsibilities
- Planning and organizing activities for preparing new product registration and maintenance of 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 existing working flows and Company procedures
- Monitoring and understanding of new RA regulations and guidelines for the area of responsibility
Requirements
- Bachelor Degree in 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;
- Dynamic, proactive and willing-to-do person;
- Excellent interpersonal, organizational and communication skills, capability in working in a team and good problem-solving attitude
Contract type: fixed term with prospects
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