of Spanish and English-speaking consumers referring to AID Atlanta, the Atlanta EMA, and Georgia for Client Services Case...
(FDA, EMA, ICH, etc.) guidelines in a biological or pharmaceutical manufacturing environment. · Experience interacting...
&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements... of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides. Hands-on experience with qualification/validation lifecycle (URS...
level in your assigned EMA/TGA. Utilizing your strong understanding of all the Ryan White Services, you will know... and procedures are in accordance with the current EMA/TGA HIV Case Management Standards. This position will work with both staff...
maintenance plans. Ensure compliance with cGMP, FDA/EMA regulations, internal quality systems, and safety standards. Support...
guidelines (e.g. ICH, EMA, FDA, etc.) Supports regulatory requests and inspections Supports the QC AD team to investigate...
and regulatory requirements (FDA, EMA, ICH, etc.);Experience in performing investigative work;Knowledge and hands-on experience...
negotiations. Act as primary or co-lead for interactions with health authorities (e.g., US FDA, EMA, MHRA, PMDA), including..., EMA, MHRA) and achieving positive compliance outcomes. Strong ability to establish partnerships, manage complexity...
conduct and in-house operational models Familiarity with ICH/GCP, FDA/EMA guidelines, and regulatory best practices...
of FDA and EMA requirements Different qualifications or responsibilities may apply based on local legal and/or educational...