regulatory requirements (FDA, MHRA, EMA), relevant industry standards, and OSHA regulations. Utilize experience and knowledge...
of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) Solid knowledge and understanding of global...
). 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 cleaning validation documentation complies with GMP, FDA, EMA, and ICH requirements. Participate in deviation investigations...
/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...
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...
with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support...
. Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.). Supports regulatory requests...
, and compliance requirements, including ICMJE, GPP, FDA, EMA, and internal SOPs. Maintain awareness of competitor publications... standards and compliance requirements (e.g., ICMJE, GPP, FDA, EMA). Experience collaborating cross-functionally with Clinical...
and familiarity with EMR systems (ModMed/EMA). Professional, detail-oriented, and compassionate toward patients...