LAVORO REGULATORY AFFAIRS SPECIALIST QUALITY PARMA, EMILIA ROMAGNA

The collaborator will be specialized in:  - carrying out gxp/iso audits of gmd contractors in full authonomy, - drafting quality agreements, - ensuring supplier...

Previous activity as supplier quality assurance...   who we are looking for purpose the collaborator will be specialized in:  - carrying out gxp/iso audits of gmd...

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

Proponiamo un’interessante opportunità come: master batch record specialist – sede: monza l’azienda nostra cliente è un’azienda globale leader nella produzione di...

Participate to regulatory inspections and customer audits as required...       develop and review quality documentation and procedures as requested...

Experience required 1-2 years in the pharmaceutical industry, experience in quality departments will be considered a plus education master’s degree, scientific (e...

Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective...

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... we strive to enhance patients’ well-being...

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

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

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

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