Monza site is a world class contract manufacturing and development facility, specialized in aseptic injectable drugs, with an increasing focus on biologics.

You will join the Regulatory Affairs team for a maternity leave substitution to support the introduction of new projects and clients. As a regulatory representative you will participate and provide regulatory guidance in dedicated project teams and, while covering this role, you will gain an unmatched experience with many different regulatory agencies and pharmaceutical companies, closely interacting with other Quality teams.

You will specifically support the Regulatory Affairs department through:

• Participating in submission activities and ensuring regulatory support to Clients
• Verifying the compliance of finished products to the registration dossier
• Activate the internal change control process to acknowledge the content of registration dossiers
• Transpose external inputs from guidelines (ICH, EMEA, FDA, GMP) and Corporate policies into internal documents, SOPs and documentation
• Managing internal documentation to be prepared for inspections

• University degree with a pharmaceutical, chemical or other relevant fields.
• Previous experience in regulatory affairs team
• Knowledge of pharmaceutical guidelines ICH, EMEA, FDA, GMP and first-hand experience with corporate quality system
• Language: ENGLISH and ITALIAN

 
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.