Regulatory Affairs Specialist

Ecolab; Verona; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading company in the healthcare sector is seeking a Regulatory Affairs Specialist to join their team in Italy. This role involves managing pharmaceutical regulatory activities to ensure compliance and promote growth of medicinal products across European markets. The ideal candidate will have a Bachelor’s degree in life sciences, relevant industry experience, and strong communication skills, working collaboratively across functions to support the regulatory framework.

Competenze

• Experience in a similar position within the pharmaceutical industry.
• Good knowledge of pharmaceutical regulations.
• Fluency in English.

Mansioni

• Manage maintenance of medicinal product licenses.
• Support cross-functional European projects.
• Monitor relevant pharmaceutical regulations.

Conoscenze

Strong written and verbal communication

Organizational skills

Ability to work independently

Regulatory expertise

Formazione

Bachelor’s degree in life sciences

Descrizione del lavoro

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

The position can be based at the Settimo di Pescantina Plant (Verona) or the Vimercate Office (MB).

What will you do

• Support cross-functional European projects to drive innovation and efficacy.
• Manage maintenance activities of medicinal product licenses for the Italian and export markets, including:
• Preparation and submission of variations.
• Creation and revision of packaging and promotional materials.
• Update of internal and official databases.
• Support audits and inspections.
• Support the pharmacovigilance system.
• Monitor relevant pharmaceutical regulations and share information internally.
• Assist other functions such as customer service and tender business with regulatory expertise.

Qualifications

• Bachelor’s degree or equivalent, preferably in life sciences (pharmacy, biology, or similar).
• Experience in a similar position within the pharmaceutical industry or with health authorities.
• Good knowledge of applicable pharmaceutical regulations, preferably with European registration procedures.
• Basic knowledge of ethical codes of practice required for GXP compliance.
• Strong written and verbal communication and organizational skills.
• Ability to work independently and collaboratively across functions.
• Ability to multi-task and prioritize effectively.
• Fluency in English (speaking, reading, and writing).

Our commitment to diversity and inclusion: Ecolab is dedicated to fair and equal treatment of all applicants and employees, promoting opportunities for minority, female, and disabled individuals based on qualifications and performance. We do not discriminate in employment matters based on race, religion, color, creed, national origin, citizenship, sex, sexual orientation, gender identity, genetic information, marital status, age, or disability.