of sterilization processes. Ensure compliance with relevant regulatory guidelines, including FDA, EMA, and ISO standards. Provide...
case-processing and reporting. Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules...
safety processes for clinical trials Knowledge of GCP, FDA, MHRA and EMA regulatory requirements for clinical trial...
and applicable FDA/EMA Guidance;Collaborate with manufacturing, engineering, facilities, and quality assurance to Responsible...
% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial...
and Enrollment, Compliance, and Payor Contracting. EMR: EMA by Modernizing Medicine Marketing support to promote your online...
: EMA by Modernizing Medicine Marketing support to promote your online presence includes organic search, online lists...
., original/supplemental approvals, expedited program designations), and health authority engagements (e.g., FDA, EMA...
all regulatory documents meet regulatory requirements and guidelines (e.g., FDA, EMA) and company standards Stay...
and effectively. In-depth knowledge of FDA, EMA, and ICH regulations for GMP compliance is essential. Responsibilities Assess... expectations. Support internal and external audits, prepare documentation, and ensure adherence to FDA, EMA, and ICH guidelines...