LAVORO STAGE REGULATORY AFFAIRS 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...

Strong understanding of gcp, regulatory requirements, and clinical trial methodologies...     engage with regulatory authorities, external experts, and key...

Strong understanding of gcp, regulatory requirements, and clinical trial methodologies...       outstanding communication skills with ability to interact with...

Stay current with regulatory guidelines and industry trends related to patient engagement and innovation in clinical research... act as the main point of contact...

Stay updated with the latest industry trends and regulatory changes...     support to commercial manufacturing division in answering questions from regulatory...

Leadership and coordination -    mobilize specific redeo team members based on the needs and stage of evaluation of each opportunity, ensuring agility and efficiency...

Each franchise is organized by stage of development with fully empowered and enhanced teams of: pipeline development and commercial portfolio management...

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...

Insert the change impact in the qms follow and execute the pre and post-implementation actions supporting the changes participates in maintenance of quality statements...

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

Insert the change impact in the qms follow and execute the pre and post-implementation actions supporting the changes - participates in maintenance of quality statements...

· 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...