Drive business-aligned regulatory strategies for GSK and ViiV established products while ensuring compliance with internal and regional regulatory requirements. • Ensure the development and execution of appropriate regulatory life cycle strategy for assigned products to meet business needs.• Execute labeling submissions as Labeling Lead for assigned products.• Maintain the label for assigned products in partnership with other labeling team members.• Lead interactions with regional regulatory authorities.• Ensure effective partnerships with stakeholders and senior leaders across Global Regulatory Affairs, Safety, Global Medical and Commercial teams.• Contribute to Regulatory Matrix Teams.

Ensure regulatory requirements are met for all nonclinical reports, documents submitted to regulatory agencies and submissions that support clinical trials applications and marketing applications.• Author nonclinical contribution to regulatory submissions, including IBs, INDS, IMPDs, NDAs and MAAs while drawing support from matrix teams across Research Units, Toxicology, DMPK, Clinical R&D and Regulatory Affairs.• Collaborate with project teams to agree strategy for resolution of specific issues for format and content relating to individual development program.• Ensure quality regulatory reporting at the nonclinical level to assure company standards for disclosure to the regulatory authorities, scientific integrity and overall safety for patients or study subjects. • Identify the critical elements of nonclinical submission components required to achieve a successful submission.• Produce written regulatory scientific communications with clarity and accuracy.• Anticipates regulators questions regarding data results or format or content.

Responsible for all aspects of DMPK studies conducted in support of the discovery programs. Performed all in vivo study procedures. Responsible for managing laboratory supplies and equipment calibration for group. • Executed in vivo pharmacokinetic studies in preclinical species, including dose administration and collection of blood, urine and tissue samples by both automated and manual methods. • Generated study protocols, data analysis, study reports and communication of results to program teams • Analysis of biological samples by LC/MS with subsequent data analysis using various software packages.

Support and execute studies relating to an insulin-secreting, glucose-responsive cell therapy for the treatment of diabetes. Apply advanced laboratory animal medicine techniques to support and execute studies using pre-clinical models of diabetes and transplantation. Perform metabolic studies pre and post-transplantation to evaluate the function and efficacy of the transplanted cells in normal and diabetic pre-clinical animal models.♦ Chemically induce diabetes in normal and immunocomprosed animals via toxin injections (ID, IM, IP, IV, SQ) and monitor health status, body weight , blood glucose, and transcutaneous graft assessment of mice both pre and post-operatively♦ Perform metabolic studies including glucose tolerance testing to evaluate function and efficacy of transplanted cells♦ Perform small animal surgery for the transplantation of cells in various anatomical sites including kidney capsule, SQ, & IP, including cells encapsulated in immunoisolation technologies♦ Maintain accurate records, perform data analysis, and communicate results through written and oral summaries to a cross-disciplinary team of personnel

Performed study procedure acclimation and executed compound administration including oral, intravenous, intramuscular, subcutaneous, intraperitoneal and intratracheal in rats, dogs, and non-human primates. Collected pre-clinical safety pharmacology cardiovascular and respiratory data using DSI PoNeMah, Buxco, and EMKA technologies and collected blood samples as needed. Maintained and managed the safety pharmacology rodent colony for use in respiratory studies by scheduling surgeries, assuring surgical success, performed behavioral screening.♦ Recorded data using telemetry models for pre-clinical safety pharmacology studies, with fully implanted, minimally invasive and jacketed systems♦ Processed and analyzed data for internal and external reports and presentations; including creation of graphic presentations with both Excel and SigmaPlot♦ Managed all laboratory functions and ensured compliance with regulatory guidelines including GLP, FDA, USDA and internal QA standards ♦ Collaborated with other scientists to develop and evaluate new technologies including respiratory inductive plethysmography and minimally invasive blood pressure models♦ Received 3 GSK Bronze Awards for work above and beyond to support 3 different projects

♦ Performed animal cesarean sections in mice, rats and rabbits♦ Performed necropsies in mice, rats, and rabbits♦ Assisted Responsible Scientist with the study related acclimation of rats, dogs, and non-human primates♦ Executed studies according to GLP standards

Provided continuing service to clients/facilities in transition though out the United States; expected tasks ranged from animal husbandry to facility administration duties.♦ Completed technical duties ranging from inoculation, colony management, bacteriology, general animal health and surveillance and quality assurance♦ Performed daily animal husbandry and cage wash tasks for mice, rats, frogs, rabbits, and guinea pigs♦ Reviewed and complied with all SOPs and quality assurance standards at each specific facility♦ Provided service at eight facilities including: National Institute of Health, Stowers Institute and Walter Read Army Institute of Research

♦ Assisted in collection of blood, rumen, feed and fecal samples from research experiments for analysis♦ Performed ELISA assay study on colostrum IgGs

♦ Conducted DNA extractions and ran PCR agarose gels♦ Performed IFA, counted cysts and made cell growth media