(e.g., EMA) Stay current on evolving regulatory requirements and translate them into actionable guidance for teams Mentor... 210/211, Part 4) and relevant FDA guidance Exposure to global regulatory environments (e.g., EMA, ICH) preferred...
processes to ensure compliance with cGMP, FDA, EMA, and other regulatory requirements. This role will act as the primary..., internal quality audit, and/or engineering facilities support. Strong understanding of cGMP, ICH guidelines, FDA, EMA...
, EMA, MHRA, and Health Canada Electronic Submission Gateways (ESG,), as well as prepare and file non-eCTD submissions..., Acrobat Adobe, ISI Toolbox, and at least one eCTD publishing system) Veeva Vault RIM, ESG Gateway, Syncplicity (EMA Gateway...
Authority inspections (FDA/EMA), and support the execution of corrective action plans. Apply risk management processes...
(e.g., EMA) Stay current on evolving regulatory requirements and translate them into actionable guidance for teams Mentor... 210/211, Part 4) and relevant FDA guidance Exposure to global regulatory environments (e.g., EMA, ICH) preferred...
FDA/EMA guidance for gene and cell therapies. Direct experience contributing to CMC sections of regulatory filings...
products Specialty knowledge of systems applications relating to job function (i.e. EMA, NextGen, etc.) Knowledge...
. Knowledge of ICD-10 and CPT coding Familiarity with the ModMed EMA EMR is strongly preferred. Thorough understanding of HIPAA...
, or related degree is preferred. Familiarity with ModMed, EMA, EMR preferred. Thorough understanding of HIPAA laws...
experience leading senior scientific professionals Strong knowledge of regulatory guidelines (FDA, EMA, ICH) Strong financial...