Site Start-Up Specialist: Reg Submissions

At Fortrea , we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist , you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will help bring life-changing treatments to...

Fortrea is seeking a Site Start-Up Specialist to coordinate site start-up activities, manage essential documents, and ensure timely regulatory submissions. You will interact with sites, sponsors, and authorities to maintain compliant, audit-ready records.The role requires 2+ years in clinical research or start-up processes, strong ICH/GCP knowledge, and...

Please submit your application in English What You'll Do: Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level Review/prepare local submission documents and performs submissions (Initial submissions, Substantial Amendments and Notifications etc.) to Ethics Committees (Central...

Please submit your application in English WhatYou'llDo: Support of Regulatory Affairs Study Start-Up (RASSU) department: Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level Review/prepare local submission documents and performs submissions (Initial submissions, Substantial...

Chiesi Farmaceutici S.p.A. in Milan is seeking an experienced Sterile Production Supervisor to join a greenfield biologics operation.You will oversee aseptic processing, participate in design, start-up, and qualification activities, and ensure GMP compliance in a site built from the ground up. The role focuses on leading operations, maintaining cleanliness,...

Join Nestlé Purina as a Packing Engineer to support the launch of a modern manufacturing site in Assago, Italy. This role involves managing capital investment projects and ensuring compliance with quality standards.You will contribute to project definitions, organize project execution, and mobilize resources while working in a dynamic and collaborative...

Chiesi in Nerviano (Milan) is seeking an experienced Secondary packaging Production Supervisor for a greenfield biologics project. You will oversee daily packaging operations and contribute to design, start-up, and validation activities to ensure GMP compliance and high-quality output.The role requires 3-5 years in secondary packaging, knowledge of GMP/GDP,...

Fortrea seeks a Site Start-Up Specialist to coordinate start-up activities, manage essential documents, and ensure timely regulatory submissions. You will join the FSPx team and work with a renowned sponsor to advance development of innovative therapies.In this role you will ensure audit-ready documentation, collaborate with cross-functional teams, and...

CTI is seeking a Regulatory Affairs Start-Up professional in Milan to support the RASSU department with submissions, country-specific requirements, and document preparation.You will liaise with Ethics Committees, Competent Authorities, and the CTI Legal team to ensure timely, compliant submissions across country sites. Strong Italian and English, plus 1–2...