LAVORO SENIOR REGULATORY AFFAIRS MANAGER PARMA, EMILIA ROMAGNA

Experience required 5 years in regulatory with good knowledge of drug development and regulatory procedures education at least bachelor’s degree in life sciences...

regulatory compliance: ensure all documents comply with the applicable regulatory guidelines and company policies, throughout the documents’ development process...

Strong understanding of gcp, regulatory requirements, and clinical trial methodologies...     collaborate with clinical program leaders, statisticians, regulatory...

It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery...

Ensure cpms maintain compliance with internal sops, gcp, and regulatory standards... strong knowledge of ich-gcp, clinical trial lifecycle, regulatory requirements...

Author, review or approve pharmacometrics reports and related sections of regulatory documents; participate in meetings with clients and regulatory agencies...

· collaborerai con marketing, quality, operations e regulatory affairs per garantire che le specifiche tecniche siano allineate alle esigenze del mercato e alle...

·        collaborerai con marketing, quality, operations e regulatory affairs per garantire che le specifiche tecniche siano allineate alle esigenze del mercato...

Participating in the analysis and interpretation of computational results, under the guidance of senior scientists... it is divided into integrated functional areas...