Regulatory Affairs Grand Rapids

AZHAR HUSSAIN

Email: **********@*****.*** Link: http://www.linkedin.com/in/Azhar-Hussain-MBA Phone: 516-***-****

EDUCATION

Doctor of Pharmacy: Anticipated June 2026

Touro College of Pharmacy, New York, NY

Doctor of Healthcare Administration: Graduated Dec. 2023

Franklin University, Columbus, OH

Thesis Title: Chronic Disease Management Via Telepharmacy From a Pharmacist Perspective: A Qualitative Approach

Master of Business Administration, Healthcare Management & Operation: Graduated Dec. 2019

Davenport University, Grand Rapids, MI

Bachelor in Biological Sciences: Graduated Dec. 2015

CUNY Hunter College, New York, NY

PROFESSIONAL EXPERIENCES

Regulatory Affairs Student Extern, Princeton, NJ Jan. 2025 – Feb. 2025

Kyowa Kirin Pharmaceutical Development

Preceptor: Stephanie Kelly, J.D., M.S.

Collaborated on the preparation and review of regulatory documents to ensure compliance with FDA, EMA, and PMDA guidelines.

Worked cross-functionally with regulatory teams to support strategy, lifecycle management, and submission planning.

Engaged in compliance assessments to align internal policies with evolving regulatory requirements.

Participated in regulatory meetings to gain insights into drug development and approval processes.

Regulatory Intelligence and Policy Student Extern Feb. 2025– Apr. 2025

Collaborated on regulatory intelligence research, analyzing global trends to assess their impact on pharmaceutical development.

Developed regulatory intelligence reports, summarizing key policy changes and industry updates.

Contributed to regulatory strategy documents, ensuring alignment with compliance initiatives.

Engaged with cross-functional teams to interpret and apply regulatory policies in drug development.

Editorial Consultant Feb. 2024 – Present

Pharmacy Times

Supervisor: Alana Hippensteele, MA

Edit 2–3 scientific articles per month, enhancing accuracy, readability, and compliance with editorial standards, leading to improved audience engagement.

Translate complex scientific data into clear, accessible articles, improving reader comprehension and increasing article engagement metrics.

Collaborate closely with the editorial team to develop structured writing frameworks, leading to more concise and impactful medical publications.

Lead editorial strategy discussions, implementing new content frameworks that simplify complex pharmaceutical topics, increasing readership retention.

Pharmacist Intern, Long Island, New York Feb. 2024 – Present

Mount Sinai South Nassau Hospital

Supervisor: Ted Vanikiotis, Rph

Utilize Sunquest software to optimize medication management, reducing workflow inefficiencies. Accurately prepare 300+ IV bags per shift, ensuring 100% dosage precision for TPN bases, bicarbonate, thiamine, insulin, and other critical medications.

Manage and distribute medication carts for 200+ patients daily, ensuring 100% adherence to dosing schedules and enhancing patient safety.

Collaborate with pharmacists, physicians, and nurses to implement 50+ MTM interventions per month, reducing medication errors and improving patient recovery rates.

Maintain accurate patient records in alignment with hospital protocols, facilitating real-time communication among healthcare teams and improving treatment accuracy.

INTERNSHIPS

ASHP Medication Safety Scholars Program Aug. 2024 – Aug. 2025

Emily Jerry Foundation

Preceptor: John Hertig, PharmD, and Christopher Jerry

Selected as 1 of 5 PharmD students nationwide for the prestigious ASHP Medication Safety Scholars Program.

Engaging in medication safety leadership training to develop expertise in error prevention, quality improvement, and risk mitigation.

Collaborating with pharmacists, regulatory experts, and patient safety advocates to enhance clinical best practices.

ORAQ Regulatory Affairs Training Program Sep. 2024 – Oct. 2024

Duke University School of Medicine

Completed structured regulatory training covering FDA drug/device regulations, IND/IDE submissions, and clinical study requirements.

Gained foundational knowledge of regulatory strategy, compliance, and FDA interactions for pharmaceutical product development.

Analyzed case studies on drug approval pathways and quality assurance processes.

Pharmacy Quality Alliance (PQA) May 2023 – Oct. 2023

2023 PQA Healthcare Quality IQ (HQIQ)

Supervisor: Kyra Leonard, PharmD

Developed a pharmacist-led Quality Improvement Health Plan to improve medication adherence in diabetes mellitus patients as part of the HQIQ Program.

Completed weekly lectures, seminars, and a comprehensive final examination, gaining expertise in medication use quality, healthcare policy, and patient adherence strategies.

Applied evidence-based methodologies, including PICK Chart, SMART Goals, Root Cause Analysis (5 Whys), and PDSA Cycle, to analyze barriers to medication adherence and propose solutions.

Designed an independent quality improvement proposal, implementing a pharmacist-driven intervention focused on patient education, adherence tracking, and chronic disease management.

TEACHING EXPERIENCE

Pharmaceutical and Biomedical Sci. Depart., Touro University, NY Aug. 2023 – Present

Position: Teaching Assistant

Advisor: Dr. Sidhartha D. Ray, Ph.D., FACN

Course: PBSN 527 Pharmacology I (4 credits), PBSN 529 Pharmacology II (3 credits)

Healthcare Admin. Depart., Franklin University, Columbia, OH May – July 2020, 2021, 2022

Position: Adjunct Lecturer

Advisor: Dr. Alyncia Bowen, Ph.D.

Course: HCM-210 Healthcare Foundations (2 credits)

CONFERENCE PRESENTATIONS

1.Pharmacists on the Digital Frontline: A Qualitative Study on Improving Telepharmacy Implementation, Communication, and Technology for Chronic Disease Management

A Hussain, A Bowen - ASHP Midyear New Orleans, LA, 2024

2.Neuro-Regenerative and Neuroplastic Effects of Thymoquinone on Alzheimer's Disease

A Hussain, M Liu, SD Ray - ASHP Midyear Anaheim, CA, 2023

3.Clinical Conundrums: Differentiating Monkeypox From Similarly Presenting Infections

A Hussain, T Maxwell – ASHP Midyear Las Vegas, NV, 2022

SELECTED PUBLICATIONS

Total Publications – 79

Total Citation – 2500+

H-Index – 20

Full list of publications available via Google Scholar

Book Chapters

1.Hussain A, Kheiri S, Milch CR, et al. Recent clinical studies on side effects of antiprotozoal and antiparasitic drugs. Side Effects of Drugs Annual. 2024;46(1):317-324. https://doi.org/10.1016/bs.seda.2024.10.001

2.Hussain A, Bloemer J. Side effects of drugs used in the treatment of Alzheimer’s disease. In: Side Effects of Drugs Annual (Print). Vol 45.; 2023:27-32. https://doi.org/10.1016/bs.seda.2023.08.018

Peer-Reviewed Journal Articles

1.Hussain, A, Bowen, AM. Exploring Pharmacist Roles in Telepharmacy for Chronic Disease Management in New York State: A Qualitative Inquiry into Improving Implementation, Patient Communication, and Healthcare Technology Support. Curēus. 16(6): e62982. Published online June 23, 2024. https://doi.org/10.7759/cureus.62982

2.Kaler J, Hussain A, Patel K, Hernández T, Ray SD. Respiratory Syncytial Virus: A Comprehensive Review of Transmission, Pathophysiology, and Manifestation. Curēus. Published online March 18, 2023. https://doi.org/10.7759/cureus.36342

oCited by Pfizer: “Respiratory Syncytial Virus: Burden of Disease in Infants.”

oCited by Sanofi: “New survey reveals that almost two-thirds of parents are concerned about respiratory syncytial virus (RSV) this winter season.”

3.Hussain A, Kaler J, Lau G, Balk TJ. Clinical Conundrums: Differentiating Monkeypox From Similarly Presenting Infections. Curēus. Published online October 4, 2022. https://doi.org/10.7759/cureus.29929

HONORS & AWARDS

Dean’s List, Touro College of Pharmacy Fall 2022 – Present

Dean’s List, Franklin University Fall 2020 – Winter 2023

Presidential Merit Scholarship, Touro College of Pharmacy Fall 2022 – Present

PROESSIONAL MEMBERSHIP & LEADERSHIP

Admissions Ambassador, Touro College of Pharmacy Fall 2022 – Present

President-Elect, New Jersey Pharmacists Association (NJPhA) Fall 2023 – Fall 2024

Member, National Community Oncology Dispensing Association (NCODA) Fall 2023 – Present

Member, American Society of Health-System Pharmacists (ASHP) Fall 2022 – Present

Member, American College of Clinical Pharmacy (ACCP) Fall 2022 – Present

Member, American Pharmacists Association (APhA) Fall 2022 – Present

CERTIFICATIONS

Pharmacy Intern with Immunization Privileges - NYS Education Department Exp: Jul 2028

Medication Therapy Management Services Certification – APhA Issue: Dec 2024

Medication Safety Professional Certificate – ASHP Issue: Oct 2024

Project Management: Healthcare – PMI Registered Education Provider Issue: Dec 2023

Good Clinical Practice - The National Institute on Drug Abuse (NIDA) Exp: Jul 2026

Naloxone Training - NYC Department of Health and Mental Hygiene Issue: Dec 2022

COVID-19 Contact Tracing – Johns Hopkins University Issue: Oct 2021

NYS Citizen Public Health Training Program - NYS Department of Health Issue: Jul 2021

Basic Life Support (BLS) – AHA American Stroke Association Exp: Aug 2026

Advanced Cardiac Life Support (ACLS) – National Health Care Provider Solutions Exp: Jun 2025

Pediatric Advanced Life Support (PALS) – National Health Care Provider Solutions Exp: Jun 2025

EKG & Phlebotomy Certification – CUNY Medgar Evers College Issue: Aug 2011

SKILLS

Healthcare & Pharmacy Systems: EPIC, DoseEdge, Pyxis, Cerner EHR, Sunquest

Data Analysis & Research Tools: MATLAB, SAS, Excel, Visio

Regulatory & Compliance: Good Clinical Practice (GCP), FDA & NIH Regulatory Guidelines

Project Management & Operations: eCW, eCares, Microsoft Outlook

Languages: Fluent in English, Urdu, Punjabi Conversational in Hindi

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