Regulatory Affairs Expert

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7s1o28

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

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 commu

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7s1o28