Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors
Experience supporting interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related...
Experience supporting interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related...
to qualification of systems and processes Working knowledge of US FDA CFRs and European EMA, including ICH regulations Experience...
with regulatory standards (e.g., GMP, FDA, EMA), accrediting organizations (e.g., FACT) and industry best practices. Drive innovation... requirements, including FDA, EMA, and other global and state health authorities, for the development and manufacturing of cell...
. This includes understanding of GxP regulations, FDA 21 CFR Part 11, EMA Annex 11, and core quality workflows. Must possess a clear...
and laboratory support;EMA / EMR in place Competitive compensation package with malpractice coverage, CME, 401(k), flexible time...
(not required) Opportunity to supervise advanced practice providers (compensated) Utilize EMA / EMR software in a modern, inviting atmosphere...
staff and EMA / EMR Competitive compensation, comprehensive benefits, loan repayment and partnership potential Location...
provide scribing and administrative support EMA electronic medical record system Compensation & Benefits Income...
equipped, EMA-enabled clinic. The role does not require supervision of advanced practice providers, allowing you to stay...
, and EMA EMR Competitive compensation model with guaranteed base, collections-based upside, comprehensive benefits and CME...