Regulatory Affairs Specialist

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).

What will you do

This position contains tasks related to pharmaceutical regulatory area.

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

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 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 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 origincitizenship status sex sexual orientation gender identity and expressions geneticinformation marital status age or disability.