Regulatory Digital Intern

Position: Regulatory Digital Intern – RIM & Regulatory Processes
Location: Bologna – Alfasigma Headquarters
Duration: 6 months

At Alfasigma we are looking for a detail-oriented and digitally skilled intern with a strong interest in Regulatory Affairs and process transformation to join our Global Regulatory Sciences team. This internship offers hands-on exposure to regulatory operations and digital initiatives, providing the opportunity to contribute to impactful projects that support business and compliance needs.

Key Responsibilities:

The intern will support the team in the following activities:

Maintain and update regulatory data and records in company systems (Veeva Vault RIM) across the product lifecycle;
Contribute to the traceability of regulatory activities (variation planning, timelines, approvals) and support related reporting;
Assist in the review and standardization of departmental SOPs and Work Instructions;
Monitor official sources (EMA/Health Authorities) and prepare summaries highlighting potential regulatory impacts;
Collaborate with colleagues and cross-functional stakeholders to ensure data completeness and consistency, keeping trackers and dashboards up to date.

Requirements:

Recent graduate in a scientific discipline; a Master’s in Regulatory Affairs is a plus;
Strong digital mindset and proficiency with Microsoft 365;
Attention to detail, strong organizational skills, teamwork and problem-solving attitude;
Good command of English, both written and spoken.

Preferred Skills:

Basic understanding of eCTD and submission flows;
Interest in IDMP/SPOR requirements and RIM/EDMS systems;
Ability to perform data quality checks and prepare reports (e.g., advanced Excel).

What We Offer:

Hands-on experience in Regulatory Affairs processes and systems, with end-to-end visibility;
A structured learning pathway with progressive objectives, dedicated mentoring, and regular feedback;
A collaborative environment within a department undergoing digital transformation.

Company:

Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in many countries, including Italy, the US, Spain, Germany, Mexico, and China; production sites in Italy (Pomezia, RM; Alanno, PE; Sermoneta, LT; Trezzano Rosa, MI), Spain (Tortosa, Baix Ebre), and the United States (Shreveport, Louisiana); and R&D labs in Italy (Pomezia and Bergamo). Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products, contributing to its mission to provide better health and a better quality of life for patients, caregivers, and healthcare providers. It focuses on three main therapeutic areas: Gastroenterology, Vascular, and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals.