gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA and FDA-approved manufacturing suites, fill...
of clinical operations staff. Has a thorough knowledge of the clinical development process, FDA, EMA and other regulatory...
Technology: A fully-equipped office with EMA software is used to streamline your workflow, allowing you to focus on what matters...
for assigned programs, ensuring alignment across US (FDA), EU (EMA), UK (MHRA), Japan (PMDA) and other target markets. Lead the... of contact via regional consultants/services for health authority interactions across multiple regions, including EMA (Scientific...
documents and regulatory responses Experience in leading writing activities for major US and/or EMA regulatory submissions...
documents and regulatory responses Experience in leading writing activities for major US and/or EMA regulatory submissions...
for assigned viral vector-based gene therapy programs, ensuring alignment with FDA, EMA, and ICH expectations. · Lead preparation... of global CMC regulatory requirements for gene therapy products, including ICH guidelines (Q5A–Q14), FDA CBER guidance, EMA...
and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively...
, EMA, or other worldwide regulatory agencies Develop software systems to generate displays of clinical study data... programming team leader or manager Fluency in English and Chinese Strong knowledge of relevant regulatory (FDA, NMPA, EMA, PMDA...
closely with a collaborative, team-oriented staff to ensure exceptional patient outcomes Utilize modern EMR/EMA systems...