. Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.). Supports regulatory requests...
of GMP quality systems in accordance with ICH, FDA, EMA, and other global regulatory requirements Provide quality oversight...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) Solid knowledge and understanding of global...
, FDA, and EMA standards. The Manager will effectively communicate results and issues to peers and management with excellent... analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards Manage/validate SLIMstat software...
/EMA regulations and ICH guidelines. Provide clear and valid regulatory guidance and direction to other departments... decision by health care regulatory authorities, specifically including FDA and EMA. Knowledge and management of the regulatory...
). This position requires hands-on regulatory writing expertise aligned with ICH, FDA, and EMA expectations, strong cross-functional...: Ensure compliance with ICH guidelines, FDA/EMA guidance, company SOPs, and style conventions Contribute to template...
and familiarity with EMR systems (ModMed/EMA). Professional, detail-oriented, and compassionate toward patients...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites... Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
resolution. Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry... requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations. Prepare and contribute to regulatory submissions...