regulations (e.g., FDA, EMA, ICH). Support continuous improvement initiatives within PV operations. Facilitate the generations...
skills and familiar with ICH/FDA/EMA guidance/guidelines Excellent interpersonal skills with strong oral/written...
. Bring familiarity with FDA, EMA, ICH, and eCTD workflows Preferred but not required: Advanced degree and/or Regulatory...
. Knowledge & Experience (preferred): Oncology drug development experience is highly desired. Regulatory submission (US FDA, EMA...
laboratories, and service providers. Support regulatory (FDA, EMA) and internal audits/inspections per procedures and applicable...
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...
or emerging biotech company environment. Global regulatory experience including FDA and EMA, other regions a plus. Demonstrated...
meet pharmaceutical industry standards and regulatory requirements including FDA, EMA, and other applicable guidelines...
management tools (i.e., FMEA, risk assessments) Experience supporting regulatory inspections and audits (e.g., FDA, EMA, PIC...
any/all of the following equipment: Microsoft 365 apps, fax, email, phone, Klara, EMA, ModMed, iPAD, NoahFace (biometric timeclock...