within the cosmetic service line Designed for efficiency - brand-new office, EMA / EMR, and workflows built to protect physician...
Responsibilities: Act as a superuser for the EMA ModMed system, providing guidance to both providers and medical assistants...
laboratories, and service providers. Support regulatory (FDA, EMA) and internal audits/inspections per procedures and applicable...
management tools (i.e., FMEA, risk assessments) Experience supporting regulatory inspections and audits (e.g., FDA, EMA, PIC...
regulatory guidance (FDA, EMA, ICH) on nonclinical safety requirements;proactively assess and communicate implications for AIRx... Expert knowledge of ICH guidelines, FDA and EMA non-clinical expectations, and the regulatory context governing non-clinical...
. Bring familiarity with FDA, EMA, ICH, and eCTD workflows Preferred but not required: Advanced degree and/or Regulatory...
is required. Experience authoring CMC dossiers for FDA, EMA and other regulatory agencies is required. M.Sc. or Ph.D. in Analytical Chemistry...
. Knowledge & Experience (preferred): Oncology drug development experience is highly desired. Regulatory submission (US FDA, EMA...
skills and familiar with ICH/FDA/EMA guidance/guidelines Excellent interpersonal skills with strong oral/written...
compliance requirements (FDA, EMA). Proven ability to lead cross-functional teams, manage multiple concurrent projects...