. Knowledge & Experience (preferred): Oncology drug development experience is highly desired. Regulatory submission (US FDA, EMA...
is required. Experience authoring CMC dossiers for FDA, EMA and other regulatory agencies is required. M.Sc. or Ph.D. in Analytical Chemistry...
, EMA, ICH, etc.). Ability to assess product benefit-risk profiles and interpret clinical and post-market safety data...
(plan). Regulatory agency's (e.g. FDA, EMA, etc.) guidelines are followed where appropriate. All raw data, documentation...
. Bring familiarity with FDA, EMA, ICH, and eCTD workflows Preferred but not required: Advanced degree and/or Regulatory...
activities comply with relevant regulations, ethical standards, and industry best practices (FDA, EMA, ICH-GCP) Develop..., regulatory requirements (FDA, EMA, ICH-GCP), and data governance principles Proven track record of leading transformational...
preferred Experience utilizing Modernizing Medicine / EMA Electronic Medical Record (EMR) highly preferred....
. On average, physicians see 35 patients per day, with the help of clinical assistants and support staff. The practice utilizes the EMA...
skills and familiar with ICH/FDA/EMA guidance/guidelines Excellent interpersonal skills with strong oral/written...
will be a plus Preferred - Similar knowledge of EMA, Latin America and middle-east countries will be a plus - 3 - 5 years of hands... is highly desirable. - As a CMC reviewer (assessor) with FDA or EMA is highly desirable. Educational Qualifications...