Regulatory Affairs Specialist

Ecolab Life Sciences; Verona; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading global life sciences company is seeking a Regulatory Affairs Specialist in Verona, Italy. The role involves supporting regulatory compliance for pharmaceutical activities across Europe, handling product licenses, and collaborating with various functions. Ideal candidates should have a Bachelor's degree in life sciences, experience in the pharmaceutical industry, and fluency in both English and Italian. This full-time position is ideal for an entry-level professional eager to influence the pharmaceutical field.

Competenze

• Experience in pharmaceutical regulatory activities.
• Good knowledge of applicable pharmaceutical regulations.
• Fluency in English and Italian required.

Mansioni

• Support Cross-Functional European Projects.
• Manage maintenance activities of Medicinal Product Licenses.
• Prepare and submit variations to product licenses.

Conoscenze

Experience in pharmaceutical industry

Knowledge of pharmaceutical regulations

Fluency in English

Fluency in Italian

Proficiency in Microsoft applications

Ability to work independently

Proactive approach

Ability to multi-task

Cross-functional collaboration

Formazione

Bachelor’s degree in life sciences

Descrizione del lavoro

Overview

Join to apply for the Regulatory Affairs Specialist role at Ecolab Life Sciences. 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 You Will Do

• 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).

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 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.

Our Commitment to a Culture of Inclusion & Belonging

Ecolab is committed to fair and equal treatment of associates and applicants and furthering the principles of Equal Opportunity to Employment. 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.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Legal