Euna Regulatory Affairs Specialist

11 ore fa

Firenze, Italia Menarini Group A tempo pieno

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
- 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.

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