Intern - Global Regulatory Affairs

Chiesi is a Company with a focus on 3 main areas: Air, Care, Rare.
Global Regualtory Affaires -CMC is a 20-people team, whose members are located in different countries, and that aims to provide an end-to-end support in Regulatory-CMC activities, for products on the market or still under development.

In this context, GRA-CMC DEV Unit (8 people) focuses on Pipeline of projects in development.
The intern will be introduced in a multinational environment, with the aim of supporting the activities of GRA-CMC DEV within Quality regulatory documentation, Quality regulatory guidelines monitoring and understanding and Quality regulatory strategic inputs to Technical Departments, in the context of clinical development and marketing applications.

In particular, the intern will support the Biologics and Small molecules projects in both early (phase 1 and phase 2) and late (phase-3 and management of BLA/MAA/NDA) stages, supporting Air and Care areas.The regulatory approach is world-wide with the need of approaching primarily major countries (EU, US, China, Japan) regulatory quality requirements.

Main activities:

• Receive appropriate training on the Company, applicable processes and reference legislation
• Manage regulatory quality documents (IMPDs/INDs) in the context of Technical Teams
• Supervise the activities of external partners (companies, CMOs)
• Archive and provide a summary of the main documents (reports, protocols)
• Interact with many internal and external stakeholders like: Global Technical Development, Quality Assurance, Global Regulatory Affairs TA managers, Clinical department, Authorities

Education: Master’s degree in scientific disciplines (CTF, Pharmacy, Chemistry, Biology, Biotechnology, Medicine). A post master's degree in Regulatory Affairs, Biotechnology or Clinical Research will be consider a plus.

Technical Skills:

• Basic knowledge on pharmaceutical development and regulatory guidances in Europe and extra Europe
• Proficient with Microsoft Office suite

Soft skills:

• Good planning and organizational skills
• Ability to analyse, synthesise and to link and interpret different information
• Ability to work in a team

Languages: Fluent in English. Study experience abroad is a plus.

Contract and benefit:
6 months internship  
Monthly Reimbursement of 1000 Euros 
Meal vouchers for each day of remote activities and Free access to internal canteen for lunch 
Free shuttle reserved to Chiesi employees from Parma railway station to Chiesi HQ and/or free pass to the urban public transport service 

Ti senti la persona giusta per questa posizione?
📩 Candidati:
- online nella settimana dal 27 ottobre al 2 novembre
- direttamente allo stand di Chiesi a Roma il 28 ottobre