pipeline into reality bringing lifesaving medicines to our patients worldwide. Global Impact: Collaborate with colleagues... future of biologics on a global scale. Key Responsibilities: Technical Strategy: Deliver robust DS strategies...
employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years... expertise in regulatory and compliance requirements for microbiological methods and specifications, including ICH, FDA/EMA...
across the Regulatory Affairs (RA) organization. This includes project management in support of all Global Regulatory Product... for developing and implementing regulatory strategy and tactics for development and marketed products in support of Global Regulatory...
and global Teva partners. How you'll spend your day All areas of responsibility listed below are essential to the... in a scientific or engineering discipline, or equivalent education/experience. Minimum 5 years of relevant progressive experience...
: - Bachelor’s degree in a scientific or engineering discipline. - 10 or more years of experience in Quality roles in a highly... regulated environment (EMA/ FDA/ MHRA). - 5 years or more of experience in quality management roles for manufacturing...
across the Regulatory Affairs (RA) organization. This includes project management in support of all Global Regulatory Product... for developing and implementing regulatory strategy and tactics for development and marketed products in support of Global Regulatory...
, and applicable global requirements (FDA, EMA, Health Canada, PMDA, NMPA). Coordinate inputs from internal SMEs (PD, AD..., Manufacturing, Engineering, QC, QA) and external writers/consultants. Ensure traceability to source documents, reports, and GMP...
development, standardization, implementation, monitor effectiveness and continuous improvement of Quality Systems, global... of local and major international authorities like EMA and US FDA for products and process, High level of understanding...
within our Digital team, you will be part of the iCMC Digital Transformation, a global top initiative that aims at building competitive... throughout the analytical-to-manufacturing pipeline Ensure digital solutions meet GMP, GLP, and regulatory standards (FDA, EMA...
within Global Clinical Affairs, the Senior Clinical Database Developer is responsible for leading the design, development..., and ongoing maintenance of clinical study databases supporting global medical device clinical trials. This role serves...