Director, Nonclinical Regulatory Writing and Submission Support, Team Lead
to global submissions and submission content (e.g., FDA/EMA/PMDA regulations;ICH guidance and familiarity with GLP/GCP...
to global submissions and submission content (e.g., FDA/EMA/PMDA regulations;ICH guidance and familiarity with GLP/GCP...
processes, ensures compliance with regulatory standards (such as FDA, EMA), and collaborates with cross-functional teams...
with biopsies and minor office surgeries is a plus Experience with EMA EMR system is a plus Minimum post high-school education...
technologies and formulation processes, preparing development plans, and ensuring compliance with cGMP, FDA, and EMA regulations... production. Ensure compliance with cGMP, GLP, GCP, FDA, and EMA guidelines. Identify and support initiation of Deviations...
& Qualifications 1-2 years of recent medical office experience or in a similar capacity is required Experience with EMA and NextGen...
in NextGen PM and EMA EHR. Acts in a manner consistent with company philosophy, goals and objectives. Promotes teamwork...
processes, ensures compliance with regulatory standards (such as FDA, EMA), and collaborates with cross-functional teams...
clinician role in NextGen PM and EMA EHR and monitors, assigns and personally participates in delivery of EMR and coding...
and guidelines (e.g., ICH, FDA, EMA) related to stability testing Proficiency in Empower and data analysis software including JMP...
and submission content (e.g., FDA/EMA/PMDA regulations;ICH guidance;GLP/GCP requirements;SEND requirements...