on a global or multi-regional scale. Strong understanding of healthcare regulatory frameworks, including but not limited to EMA...
Mohs day Melanoma referrals / Adding communication notes in EMA Attend biweekly manager meetings. Ensure...-train new hires/staff Adjust provider schedule per the guidelines Respond to Klara, Emails, Teams and EMA tasks...
of products regulated by FDA CBER or CDER or EMA. Intermediate to advanced experience supporting Cell and Gene Therapy... with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines. Every day, Lonza...
regulatory agencies (e.g., FDA, EMA), publications, ad hoc and other statistical analysis requests Carry out integrated analysis...
. Understanding of Data Integrity (per FDA and EMA) in the context of manufacturing systems would be ideal. Manage the lifecycle...
of cGMPs and regulatory guidance requirements (FDA, EMA, PIC/S, etc.). Previous leadership of commercial GMP manufacturing...
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...
, and climate policy. BA/BS required. Preferred: Energy efficiency training (IEMA, EMA, Certified Energy Manager (CEM...
principles, cGMP regulations, and regulatory requirements (e.g., FDA, EMA). You have experience with aseptic filling equipment...
key application activities Manage interactions with country regulatory authorities (FDA, EMA, HC, etc) for assigned...