Regulatory Affairs Specialist

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Solo per membri registrati

Verona

EUR 50.000 - 70.000

Sii tra i primi a mandare la candidatura.

Ieri

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.