Evinova enables global life sciences to accelerate better health outcomes through innovative digital health solutions... organization building, hands-on customer delivery, and commercial ownership. The leader will recruit and scale a global...
solutions meet global regulatory standards, including ICH, EMA, FDA, and other applicable guidelines. You will drive... and Experience: Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Sciences, Engineering, or a related field 5+ years...
. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team... compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.). Additional...
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...
Ensure quality operations comply with global regulatory requirements (e.g., FDA, EMA, PMDA) and internal standards. Support..., enhance risk management practices, and optimize global quality system processes across a global quality organization...