. Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.). Supports regulatory requests...
regulatory requirements (FDA, MHRA, EMA), relevant industry standards, and OSHA regulations. Utilize experience and knowledge...
/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...
guidelines, the global regulatory authorities for pharmaceutical development including FDA, MHRA and EMA, the relevant industry...
, 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...
, 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 GMP quality systems in accordance with ICH, FDA, EMA, and other global regulatory requirements Provide quality oversight...
regulatory agencies (FDA, EMA, Health Canada, etc.) and the biotech industry, including but not limited to 21 CFR, GxP, HIPAA...
. Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.). Supports regulatory requests...
validation documentation complies with GMP, FDA, EMA, and ICH requirements Participate in deviation investigations, CAPAs... Familiarity with biopharmaceutical or biotech manufacturing environments Experience supporting regulatory inspections (FDA, EMA...