agencies such as FDA (including advisory committees), EMA, CDC, AHRQ, and WHO;and at scientific conferences. Maintains...
for Gene Therapies. The campus features two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility...
processes, ensures compliance with regulatory standards (such as FDA, EMA), and collaborates with cross-functional teams...
alignment on CQV activities and project timelines. Ensure compliance with regulatory requirements (FDA, EMA...
enforcement, fire personnel, emergency responders/ EMA, PPL on-call personnel ,TCC, DCC, Fusion Operations. Qualifications...
skills Must have experience with EMR;Knowledge of EMA highly preferred Must be a strong and fast at typing...
with FDA, EMA, and related regulations. Develop/improve standard operating procedures (SOPs), work instructions, and quality... of cGMP, FDA, EMA, and USP guidelines relevant to packaging and labeling, and experience filing label artwork changes...
Knowledge: Comprehensive understanding of global regulatory requirements (FDA, EMA, ICH, etc.) and drug development...
enforcement, fire personnel, emergency responders/ EMA, PPL on-call personnel ,TCC, DCC, Fusion Operations. Qualifications...
authorities (e.g., US Food and Drug Administration [FDA], European Medicines Agency [EMA], Pharmaceuticals and Medical Devices...