Regulatory Affairs Specialist: EU

Alfasigma is seeking a Regulatory Affairs Specialist to support local Italian product regulatory strategies, including new MA and lifecycle management. You will prepare dossiers, interact with AIFA, and ensure compliant submissions for local and global brands. You will collaborate with Quality, Medical Affairs, Market Access, and cross-functional teams,...

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...

Your RoleManage 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

Select how often (in days) to receive an alert: 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...

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

Select how often (in days) to receive an alert: 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...

Select how often (in days) to receive an alert: 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...

Select how often (in days) to receive an alert: 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...

Select how often (in days) to receive an alert: 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...