(FDA, EMA, MHRA, etc.) and other government and local agencies required. Must have strong working knowledge of the end...
, EMA) and healthcare laws Excellent communication, analytical and problem-solving skills Prefer experience working...
complex with high quality Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines Intermediate understanding...
, preparing development plans, and ensuring compliance with cGMP, FDA, and EMA regulations. Responsibilities Lead and support..., GCP, FDA, and EMA guidelines. Identify and support initiation of Deviations, CAPAs, and Investigations. Essential...
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...
of Quality Systems supporting cGMP manufacturing and testing. Experience with FDA and/or EMA inspections preferred Leadership...
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...
practices and clean room operations: Advanced knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics...
agency expectations (FDA, EMA, ICH, etc.). Strong knowledge of regulatory submission systems (eg, Veeva Vault QMS, eCTD, CTD...
of completing all patient Demographics to avoid claim rejections Ability to post copays into EMA Ability to verify straight...