Glory Evulukwu

Regulatory Affairs Specialist with experience at AbbVie Inc., focusing on compliance and global submissions. I possess an expertise in regulatory documentation and cross-functional collaboration which has driven significant process improvements and enhanced submission efficiency. My strong analytical and communication skills facilitate successful product approvals, complemented by a commitment to staying updated on legal regulations for continuous compliance.

• Regulatory Affairs Specialist Global Submission Support, AbbVie Inc., 08/01/23 - Current, Prepared, compiled, and submitted regulatory documentation for product approvals, renewals, and modifications to regulatory authorities, Ensured all submissions met stringent guidelines and timelines, Managed Global requests for GMP’s, LOA’s, POA’s, Declaration Letters, CPP’s, ML’s, and other Regulatory requests within the system, Maintained thorough knowledge of regulatory requirements and changes in regulations and ensured ongoing compliance of marketed products with local and international regulations, Collaborated with multiple health authorities (e.g., EMA, HPRA) to secure certificates for submission purposes, Worked closely with cross-functional teams including labeling team, CMC, Quality Assurance, and Clinical Operations to gather necessary information for regulatory submissions, Communicated effectively with regulatory authorities and responded to queries in a timely manner, Supported regulatory audits and inspections by preparing necessary documentation and providing responses to regulatory findings or queries, while staying up to date with regulatory developments and sharing knowledge through training sessions or documentation updates, Coordinated and implemented multiple system process enhancements within the Global Submission Support Team, Initiated a Patient Centricity program to educate employees on AbbVie products, Leveraged the FDA’s CDRH (Center for Devices and Radiological Health) and CDER (Center for Drug Evaluation and Research) to submit product applications for the U.S. market, Developed forecasts for future approvals and submissions using historical data from the system, Contributed to multiple cross-functional meetings for company initiatives and new product development, Executed a Clinical Trial Analysis project for the JPAC region to enhance both their processes and ours, thereby facilitating submissions
• Pharmacokinetics & Applied Patient Care Tutor, Chicago State College of Pharmacy, 05/01/21 - 05/01/23, Reviewed classroom or curricula topics and assignments, Assisted students with homework, projects, test preparations, and other academic tasks, Worked with students to help them understand key concepts, Delivered individualized instruction on observation, assessment, decision-making, and patient health teaching, Provided immediate and constructive feedback to students individually, Implemented new educational techniques such as studying strategies, and test taking skills to boost student comprehension
• Drug Delivery, Script Drop, 08/01/20 - 11/01/21, Picked up and delivered a high volume of prescriptions from Jewel Osco, Provided excellent customer service by delivering prescriptions with professionalism and courtesy, Addressed any customer inquiries or concerns promptly and escalated complex issues to the appropriate channels, Maintained effective communication with the Script Drop team and customers regarding any changes, delays, or issues related to deliveries, Assessed and resolved any delivery-related challenges, such as locating difficult addresses or navigating complex routes, Collaborated with the Script Drop team to find solutions for exceptional circumstances, Followed all applicable laws, regulations, and company policies related to the transportation and delivery of medications, Maintained confidentiality and handled sensitive customer information securely
• Pharmacy Intern, Walgreens, 05/01/19 - 07/01/20, Processed and dispensed a high volume of written, oral and electronic prescriptions, Utilized strong multitasking ability to manage operations of drive through, drop off, pick up as well as filling during 8-hour shifts, Analyzed, typed, and filed prescriptions based on their classification, Reported prescription errors to the pharmacist on duty and adhered to company policies and procedures in relation to pharmacy errors, Administration of vaccines, Conducted daily patient calls in order to facilitate drug safety and efficacy, Prepared and distributed medications according to established policies, procedures, and protocols, Earned trust with customers by reviewing patient medication profiles and medical records to screen for appropriate drug selection, dosing, contraindications, side effects, and therapeutic outcomes to properly counsel medication regimens
• Pharmacy Technician, Walgreens, 01/01/18 - 01/01/19, Responsible and held accountable for registering all related sales on assigned cash register and collects and handles cash as required, Analyzed, typed, and filed prescriptions based on their classification, Restocked pharmacy drugs based on deliveries from warehouse, Processed and dispensed a high volume of written, oral, and electronic prescriptions, Administered vaccines

• Student National Pharmaceutical Association, Board Member, 05/01/19 - 05/01/23
• Student Ambassador, Chicago State University College of Pharmacy, 05/01/21 - 05/01/23
• S.T.E.M (Science Technology Engineering and Mathematics), Prairie State College, 05/01/18 - 05/01/19

• Pharmacy Intern, Walgreens Pharmacy, Community Pharmacy, 02/01/23 - 03/01/23, Assisted with filling and dispensing prescriptions under the supervision of a licensed pharmacist, Conducted medication therapy management (MTM) services and other clinical services, Interacted with patients and customers, answering questions, and providing excellent customer service, Participated in inventory management, including ordering, receiving, and stocking medications and supplies, Collaborated with other healthcare professionals, such as physicians and nurses, to provide comprehensive patient care, Participated in Walgreens training programs to enhance pharmacy knowledge and skills
• Pharmacy Intern, Alexian Brothers Medical Center, Critical Care, 01/01/23 - 02/01/23, Collaborated daily with the critical care team to ensure appropriate medication therapy for critically ill patients, Monitored and managed medication orders, including verifying dosages, routes of administration, and frequency, Collaborated with other healthcare professionals, such as physicians, nurses, and respiratory therapists, to optimize patient care at daily rounds, Provided patient education on medications, disease states, and medication-related adverse effects, Participated in continuing education and professional development opportunities to enhance knowledge and skills in critical care pharmacy, Participated in quality improvement initiatives related to medication use in the critical care setting, Utilized Epic to monitor and report patient findings while conducting medication reconciliation for discharged patients, Analyzed clinical trials and made recommendations to doctors based on findings from trials, Handled the care of multiple critical care patients at once
• Pharmacy Intern, St. Mary’s Hospital, Ambulatory Care, 10/01/22 - 11/01/22, Obtaining patients INR’s daily and adjusted warfarin dosage based on patients INR score, Utilized appropriate drug information resources to determine accurate dosage for patients based on their current scores, Conducted various medication reviews/reconciliations, Scheduling patients for follow-up appointments based on therapeutic range, Conducted patient chart reviews to ensure no drug interactions were present
• Pharmacy Intern, Community Health Pharmacy, 09/01/22 - 10/01/22, Completed various drug information requests for doctors and pharmacists regarding patient therapy/choice of drug treatment, Completed and cited references for (AMA format) one journal club about the use of SGLT 2 inhibitors and heart failure, Shadowed 4 specialty clinical pharmacists and reviewed their patients under supervision of each pharmacist, Participated in one kinetics evaluation for a Vancomycin IV drip, Obtained a greater knowledge of various inpatient hospital resources/guidelines for drug information requests, Presented both formally and informally patient case presentations to pharmaceutical staff members based on patients under admission in the hospital, Conducted a clinical trial review on the use of SGLT2 inhibitors and their benefits in heart failure, Shadowed an oncology pharmacist and learned about the verification and infusion process for patients
• Pharmacy Intern, Amazon Pharmacy, 06/01/22 - 09/01/22, Completed DUR analysis and clinical discretion surveys, Attended daily team meetings and student presentations, Completed journal clubs as well as drug information requests tasked by preceptor, Obtained introductory skills to various operational processes at Amazon Pharmacy, Attended meetings with pharmacy managers to discuss safety and quality assurance, Participated and engaged in quality assurance and safety protocol discussions
• Pharmacy Intern, ProHealth Pharmacy, 05/01/22 - 06/01/22, Formulated and compounded multiple dosage forms tailored to patient needs (including ointments, creams, gels, solutions, suspensions, troches, capsules), Administration of Covid-19 and flu vaccines to patients, Answering patient calls and assisting them with their needs such as medication checks, refills assistance, prescription status, and MTM questions, Processed and packaged prescriptions for patients to ship via FedEx
• Pharmacy Intern, St. Bernard Hospital, 01/01/21 - 04/01/21, Managing patient calls and scheduling daily COVID-19 vaccines, Developing patient TPN IV bags based on doctors’ requests, Processing inpatients medications through billing for patients, Conducted medication reconciliation for various patients to facilitate drug safety and efficacy, Providing the best patient experience through assisting the pharmacist and pharmacy team members, Reporting prescription errors to the pharmacist on duty and adhering to company policies and procedures in relation to pharmacy errors, Administration of COVID-19 vaccines
• Volunteer, Journey Care Hospice, 01/01/20 - 05/01/20, Helping patients reach out to family members, based on their behalf on visiting hours and scheduling, Sending sympathy greeting cards to deceased patient family members, Providing comfort, support, and care for patients during their end-of-life care by reading to them, offering words of encouragement, and acknowledging their spiritual beliefs
• Pharmacy Intern, CVS Pharmacy, 09/01/19 - 12/01/19, Maintain customer and patient confidentiality; verify data and billing information, Accurately create new patient profile as well as entering prescriptions into the database, Triage challenging customer concerns regarding insurance; contact insurance companies and doctors to verify information and maintain pharmacy regulations, Analyze and type prescriptions ensuring controlled substances and narcotic prescriptions are not filled prior to due date; communicate with pharmacists and utilize medication documentation software to input, count and dispense medications safely and accurately

• Doctor of Pharmacy, PharmD, Chicago State University, College of Pharmacy, 05/01/23
• Illinois Pharmacy Technician License, Department of Financial and Professional Regulation, 03/31/23, 049247907
• Indiana Pharmacy Intern License, Indiana Board of Pharmacy, 09/30/23, 45023492A
• APhA Pharmacy-Based Immunization Delivery Certification
• American Heart Association Cardiopulmonary Resuscitation Certificate, 01/01/24