Regulatory Affairs Expert
Pubblicato il 30-10-2026 - ALFASIGMA in Pomezia
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Le seguenti informazioni forniscono una panoramica delle competenze, delle qualità e delle qualifiche necessarie per questo ruolo.
Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.
Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.
But our journey is far from complete In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.
Scope of the role
The role of Regulatory Affairs supports the Regulatory Strategy for Local Italian Products, both for new Marketing Authorization and Life Cycle Management Applications. The Specialist assures an effective and efficient preparation and setting up of the necessary documentation for the new Marketing Authorizations, Variation and MA renewal applications and for any modification of the dossiers of the MAs already authorized.
Your Role
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- Manage regulatory activities for assigned Rx and OTC products throughout their lifecycle, ensuring compliance with Italian and European regulatory requirements.
- Prepare, review and submit regulatory dossiers, including variations, renewals, notifications and maintenance activities, with a particular focus on quality and safety related regulatory variations.
- Under supervision, interact with AIFA and other relevant Italian regulatory institutions, ensuring timely and effective management of regulatory requests and communications.
- Support the development, review and approval of promotional and advertising materials, ensuring compliance with applicable regulations and company standards.
- Manage a portfolio of approximately 10 products, including both local and global brands, collaborating with international and cross-functional teams.
- Monitor and interpret regulatory changes, assessing their impact on the company portfolio and proactively proposing appropriate actions.
- Collaborate closely with Quality, Medical Affairs, Market Access, Pharmacovigilance, Supply Chain, Marketing, Global Regulatory, CMC, Internal and ESO Manufacturing Sites, Artwork Dept. and other internal and external stakeholders to ensure regulatory compliance and successful product lifecycle management.
- Leverage digital regulatory tools and systems to improve efficiency, data quality and regulatory processes.
- Maintain accurate regulatory documentation and databases, ensuring data integrity and audit readiness.
- Contribute to continuous improvement initiatives, promoting digital innovation and process optimization within the Regulatory Affairs Italy function.
Who are you
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- At least 2 years of experience in Regulatory Affairs within the pharmaceutical industry with focus on Italian and EU guidelines.
- Degree in Pharmacy and Pharmaceutical Chemistry and Technology (CTF). Degree in Pharmacy, Pharmaceutical Chemistry and Technology or, alternatively, Chemistry, Biology or another relevant life-science discipline.
- Master's Degree in Regulatory Affairs is considered a plus.
- Good knowledge of registration procedures and regulatory dossier preparation, including format, content and applicable in EU and Italy Market.
- Understanding of pharmaceutical regulatory processes and lifecycle management activities.
- Strong attention to detail and problem-solving skills.
- Fluency in English, both written and spoken.
- Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with electronic document management systems.
- Hands-on experience with eCTD publishing and submission tools; familiarity with Veeva RIM is considered a plus.
- Digital mindset and interest in leveraging digital tools and technologies to enhance regulatory processes.
- Strong collaboration and stakeholder management skills, with the ability to work effectively in cross-functional and international environments.
- Proactive, energetic, a