Copenhagen Municipality, Capital Region of Denmark, Denmark
● Interpreted nonclinical, clinical, and post-marketing data in the development and maintenance of Company Core Data Sheets (CCDSs), USPIs, EU SmPCs, and other global labeling documents ● Led cross-functional labeling management teams tasked with both CCDS and local label oversight ● Provided regulatory labeling support to the preparation of global labeling variation packages, health authority inquiries, and initial marketing authorizations in Canada, South Korea, Switzerland, Japan, and the Gulf markets ● Led cross-functional teams tasked with developing a target product label for several developmental products (orphan as well as biologic products) ● Developed an understanding of competitor labeling and development trends, regulatory authority precedent (EU and US), and regulatory guidelines to help guide several product development programs towards achieving the desired target product label
● Collected, analyzed, and presented retrospective HIV clinical data in the setting of Illinois correctional facilities ● Aided in the development of various research projects including the assessment of: baseline HIV-1 genotypes in the correctional setting, the value of the UIC HIV telemedicine clinic in regards to clinical outcomes, and the impact of concurrent highly active antiretroviral therapy and chemotherapy on several HIV biomarkers ● Contributed to the writing of institutional review board submissions, poster presentation abstracts, and journal articles for publication
● Oversaw the creation and management of global CMC electronic regulatory submissions ● CMC Scientific Affairs lead for the following submissions: IND, IMPD, CTA, NDA, response to agency questions, and post-approval amendments and supplements (United States and European Union) ● Created and enforced timelines to ensure CMC regulatory documents were authored, reviewed, and approved according to the global submission strategy
● Interpreted nonclinical, clinical, and post-marketing data in the development and maintenance of Company Core Data Sheets (CCDSs), USPIs, EU SmPCs, and other global labeling documents ● Served as the global regulatory labeling lead responsible for developing, driving, and executing the labeling strategy for several marketed product ranges ● Led cross-functional labeling management teams tasked with both CCDS and local label oversight ● Provided regulatory labeling support to the preparation of global labeling variation packages as well as responses to health authority inquiries ● Developed and led the implementation of a more efficient process for how LEO Pharma manages the labeling activities for various mature product categories