Regulatory Affairs Specialist

Experteer Italy; Verona; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A pharmaceutical company in Italy is seeking a Regulatory Affairs professional to support regulatory activities and ensure compliance with EU regulations. Key responsibilities include managing product licenses and supporting cross-functional projects. The ideal candidate will have a Bachelor's degree in life sciences, experience in a similar role, and fluency in English and Italian. This position offers opportunities for collaboration in a dynamic environment.

Competenze

• Experience in a similar position in the pharmaceutical industry or at health authorities.
• Good knowledge of applicable pharmaceutical regulations, preferably with European registration procedures.
• Basic knowledge of related ethical code of practice required for GXP compliance.

Mansioni

• Support Cross-Functional European Projects to drive innovation and efficacy.
• Manage maintenance activities of Medicinal Product Licenses in Italy and export market.
• Prepare and submit variations to medicinal products.

Conoscenze

Fluency in English

Fluency in Italian

Proactive approach

Ability to work independently

Ability to multi-task

Formazione

Bachelor's degree in life sciences

Strumenti

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Descrizione del lavoro

Overview

In this role you will be supporting the Regulatory Affairs Healthcare Team with implementation, execution and management of pharmaceutical regulatory activities in Italy and further European regions, ensuring compliance and growth of our medicinal product portfolio.

The position could be based in Settimo di Pescantina Plant (Verona) or in Vimercate Office (MB).

Responsibilities

• Support to Cross-Functional European Projects to drive innovation and efficacy
• Manage diverse maintenance activities of Medicinal Product Licenses on the Italian and export market, like:
• Preparation and submission of variations
• Creation and revision of packaging & promotional materials
• Update of internal and official databases
• Support audits & inspections
• Support the Pharmacovigilance system
• Monitor regulatory/pharmaceutical regulations for the relevant therapeutic areas and share information internally
• Assist other functions, like customer service and tender business with regulatory expertise

Education

Bachelor's degree or equivalent, preferably in life sciences (pharmacy, biology, or similar).

Qualifications

• Experience being in a similar position in the pharmaceutical industry or at health authorities
• Good knowledge of applicable pharmaceutical regulations - preferably with European registration procedures
• Basic knowledge of related ethical code of practice required for GXP compliance
• Proactive approach
• Ability to work independently and collaborate effectively with cross-functional colleagues at all levels of the organization
• Ability to multi-task and prioritize work
• Fluency in English (speaking, reading, and writing) and in Italian
• Proficiency in Microsoft applications (Excel, Word, PowerPoint)

Our Commitment to Diversity and Inclusion

Ecolab is committed to fair and equal treatment of associates and applicants and furthering the principles of Equal Opportunity to Employment. Our goal is to fully utilize minority, female, and disabled individuals at all levels of the workforce. We will recruit, hire, promote, transfer and provide opportunities for advancement based on individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, Ecolab will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, or disability.