Sr Associate, Manufacturing Regulatory - Temporary (12 months contract)
Consulti la panoramica del ruolo qui sotto. Se è affidabile/a di possedere le giuste competenze ed esperienze, si candidi oggi stesso.
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.
Role Purpose
The Sr Associate, Manufacturing Regulatory Affairs is responsible for supporting regulatory activities within continuous improvement and compliance projects related to products, manufacturing, and analytical processes. The role ensures that all changes are assessed, documented, and managed in compliance with applicable regulatory requirements.
Key Responsibilities
-
- Assess regulatory impact of changes related to manufacturing sites, processes, and products
- Plan and support activities associated with CMC (Chemistry, Manufacturing & Controls) variations and manufacturing site changes
- Coordinate the collection, review, and organization of GMP documentation required for regulatory submissions
- Draft and review documentation supporting CMC var