. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies... assisting and patient care. Knowledge of medical terminology. Experience with EMR systems, specifically NextGen and EMA...
and 6+ years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 5 years of GMP... agency regulations (such as the FDA, EMA) to ensure inspection readiness of department. Important Considerations...
At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated... Education PhD in Engineering, Biochemistry, or other biotechnology-related degree Experience Minimum of 5 years...
, electronic engineering, physics, etc). Global experience and a nuanced understanding of international regulatory landscapes..., Regulatory, and Validation Support Design validation studies following FDA, EMA, or MDR-aligned frameworks, including GCP/GCLP...
) in support of a global region (i.e., Americas, EMA or Asia/Pacific.) Organized with attention to detail. Excellent analytical... in one or two functional areas (i.e., Operations, Finance, Order Management, Procurement, Engineering, Human Resources or Payroll...
with ICH, FDA, EMA, and other global guidelines. Health Authority Interactions:Serve as the primary point of contact for CMC... within Regulatory Affairs responsible for the global regulatory strategy and execution related to the pharmaceutical quality...
-5pm 100% on-site (Madison, WI) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization... (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing...
digital innovation for QC laboratory Minimum Requirements/Qualifications: BS in Science, Engineering, or a related field... plus 10+ years of experience, 7 of which should be in a management role Knowledge of FDA, EMA, CFDA, PDA Regulations...
on internal and external project teams as technical subject matter expert (SME) and interfaces with global MSAT, Manufacturing.... Partner with Quality, Validation and Global MSAT to develop and implement process validation and comparability studies leading...
everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative..., life-changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch...