EUNA Regulatory Affairs Specialist

Overview:

Within the Global Regulatory Affairs department - EU and North America area (EUNA), Menarini Ricerche Spa is looking for a Regulatory Affairs Specialist with a direct report to the EUNA Therapeutic Area Manager.

The resource will be responsible of 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 & Responsibilities:

Within the EUNA Regulatory Affairs team and under the guidance of the Therapeutic Area Manager, the resource will deal with the registrations and/or life cycle maintenance activities of the products in the specialty and primary care area. It will include, at least:

• Planning/organising activities for preparing new product registration and/or maintenance of the existing registration through variation procedures and renewals
• Working in cooperation with technical internal functions (such as Quality Assurance, Medical, Marketing, Clinical, Pharmacovigilance), and local regulatory teams or external partners for the preparation of the regulatory application related to new registrations and/or 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
• Preparation and management of the paediatric application and relevant update, if any
• 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:

• Bachelor Degree in scientific environment, including, but not limited to, Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, Chemistry, is mandatory
• At least 3 years of previous experience in an international regulatory affairs department for pharma products
• Fluent in English, both written and oral
• Dynamic, proactive and willing-to-do profile
• Excellent interpersonal, organizational and communication skills, capability in working in a team and good problem-solving attitude.