Regulatory Affairs Specialist

Ecolab; Verona; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading healthcare firm in Italy is seeking a Regulatory Affairs professional to support the implementation and management of pharmaceutical regulatory activities. Responsibilities include managing Medicinal Product Licenses, ensuring compliance with regulations, and assisting cross-functional teams. The ideal candidate has a Bachelor’s degree in life sciences, experience in the pharmaceutical industry, and is fluent in English and Italian. This is a full-time position based in either Settimo di Pescantina or Vimercate.

Competenze

• Experience in a similar position in the pharmaceutical industry or health authorities.
• Good knowledge of pharmaceutical regulations with European registration procedures.
• Basic knowledge of ethical codes required for GXP compliance.

Mansioni

• Support the Regulatory Affairs Healthcare Team with pharmaceutical regulatory activities.
• Manage maintenance activities of Medicinal Product Licenses.
• Support Cross‑Functional European Projects for innovation.
• Assist other functions with regulatory expertise.

Conoscenze

Fluency in English

Fluency in Italian

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Ability to multi-task

Collaborative working

Formazione

Bachelor's degree in life sciences

Descrizione del lavoro

What will you do

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

This position contains tasks related to pharmaceutical regulatory area.

Support 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

Bachelors degree or equivalent preferably in life sciences (pharmacy biology or similar).

Qualification

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 prioritise work.

Fluency in English (speaking, reading and writing) and in Italian.

Proficiency in Microsoft applications (Excel, Word, PowerPoint).

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 utilise 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 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, colour, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age or disability.

Employment Type

Full‑Time

Experience

years

Vacancy

1