Engaged in entire scope of regulatory activities in EMEA/Pacific Asia markets, including China, Russia, Taiwan and Australia/New ZealandSupport lifecycle of nutrition products, from early-stage innovation projects through product registration and launchPerform formula assessments against local regulations to determine product complianceReview product labels for compliance to labeling regulationsMonitor the global regulatory environment for key changes, including developing Food for Special Medical Purpose (FSMP) regulations in China and Australia/New ZealandSupport the ANRA external engagement strategy for working cooperatively with Key Opinion Leaders (KOLs) and Ministries of Health (MOHs) who influence Abbott Nutrition’s position in the market

Act as Global Product Owner in IV Therapy and Nutrition division, responsible for regulatory lifecycle management from therapeutic development to registration and post-marketing activitiesCompile and submit regulatory documents for product maintenance and new product registrationSubmissions include Annual Reports, Changes Being Effected and Prior Approval Supplements (CBE and PAS), and Drug Master File (DMF) AmendmentsMonitor the safety profile of marketed products by reviewing and submitting Product Safety Update Reports (PSUR) and Periodic Adverse Drug Experience Reports (PADER)Represent Regulatory Affairs on cross-functional project teams to ensure successful product registration and lifecycle managementProvide strategic regulatory input into the development of labeling documents, including Structured Product Labeling (SPL) and Company Core Safety Information (CCSI)Responsible for Regulatory ownership of a Type III Drug Master File for a novel non-PVC container closure systemKnowledgeable on regulations and registration procedures in the United States, Canada, European Union, Asia-Pacific, and Latin AmericaSupport centralized processes within Regulatory Affairs function, such as global change control, submission management, and strategic planningPost-maketing clinical trial experience. Compliance with FDA and ICH Good Clinical Practice (GCP) regulationsDevelopment and implementation of comprehensive global regulatory strategies, including submission timeline, documentation requirements, and risk mitigationMonitor regulatory trends and pharmacopeia changes worldwide to assess the impact on product portfoliosCompile and submit responses to queries from regulatory authorities within strict deadlines

• Supervise and instruct an Organic Chemistry laboratory section of approximately 20 students during four 10-week quarters• Maintain a safe and productive laboratory environment for undergraduate students• Other regular responsibilities include: proctoring and grading hourly exams, grading weekly laboratory reports, performing a preparatory lecture prior to each laboratory experiment, and holding weekly office hours

• Crystallize proteins and oligonucleotides for structural determination to support structure-based drug design• Characterize protein-DNA interactions• Operate X-ray crystallography instrumentation to obtain diffraction data•