is required Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct...
is required Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct...
, EMA, ICH, ISO 9001, 21 CFR 210/211). This role builds and maintains compliant quality systems, drives inspection...
regulations and guidelines, including FDA, EMA, ICH, GCP, and GMP Provide person-in-plant support for drug product manufacturing..., ICH, FDA, and EMA requirements Proven ability to collaborate effectively across internal and external stakeholders Excellent...
submissions to FDA, EMA, NMPA, PMDA, etc. Able to identify data or analytical issues, and assist with providing solutions...
across clinical and commercial programs, ensuring alignment with global regulatory expectations (FDA, EMA, ICH, etc.) supporting R...
recommendations for successful execution Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA... of regulatory agencies such as the FDA and EMA Submission experience strongly preferred Direct experience with NDA/BLA...
and regulations. Must have a good understanding of cGMP requirements by FDA, EMA, and ICH. Preferred Qualifications Experienced...
/ week) split between two nearby clinics less than five miles apart Established systems using EMA / EMR to support...
guidelines, industry codes (e.g., EFPIA, FDA, EMA), and company policies. Maintain high ethical standards in external...