NADIA GRACE BUNSHAW PharmD, MS Regulatory Affairs
Boston,MA
Summary
Proficient in current pharmaceutical regulations, standards and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Capstone Project
Boehringer Ingelheim Pharmaceuticals Inc
09.2023 - 12.2023
- Global Master Dossier Analysis -Led a cross-functional team in analyzing differences between Boehringer Ingelheim's Global Master Dossier (GMD) guidances for drug substance (DS) and drug product (DP) submission, within the framework of the ICH Common Technical Document (CTD) structure, designed to meet regulatory standards across global authorities
- Identified disparities, proposed alignment strategies, and presented recommendations for harmonizing DS and DP guidances, optimizing submission processes for US New Drug Applications (NDAs).
- Developed comprehensive project plans, ensuring timely completion of milestones and deliverables.
- Fostered a positive work environment, promoting teamwork and open communication among colleagues.
Regulatory Affairs Intern
Indegene Inc
12.2022 - 07.2023
- White paper- Probability of Regulatory Success.
- Organization of the Regulatory Affairs Digital Council Summit.
- SOP Development: Clinical Study Report, ISS, ISE. Wrote and updated standard operating procedures.
- Client project development- iPlan: Pfizer, Authoring and Summarizing 505(b)(2): Amneal, Due Diligence: Assertio BD. Received, researched and resolved consumer inquiries.
- Regulatory Intelligence as a Service, Artwork and Labeling, Medical Writing, Health Authority Query Management.
- Maintained up-to-date knowledge on changing regulations by attending relevant workshops, and webinars regularly.
- Enhanced compliance with FDA regulations by conducting thorough research and analysis.
- Worked well in a team setting, providing support and guidance and exercised leadership capabilities by successfully motivating and inspiring others.
- Worked flexible hours across night, weekend, and holiday shifts while paying close attention to detail in completing assignments.
- Applied effective time management techniques to meet tight deadlines.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
Experiential Learning (XN) Project Intern
Ebb & Flo
07.2022 - 09.2022
- Directed a multifaceted initiative to devise a regulatory framework for Software as Medical Devices (SaMD), harmonizing it with FDA, EMA, and global standards
- Oversaw risk assessments, evidence generation, and compliance strategies, ensuring seamless alignment for regulatory approvals.
- Risk assessments to categorize SaMD products based on intended use and potential impact on patient safety, guiding regulatory scrutiny levels
- Aligned the project with international regulatory guidelines, including FDA and EMA standards, while ensuring adherence to industry best practices such as IEC 62304 for software development.
- Researched and analyzed data to support project-related decisions.
- Tracked project and team member performance closely to quickly intervene in mistakes or delays.
Clinical Pharmacist Intern
PSG Super Specialty Hospitals
12.2018 - 12.2019
- Ward rotations: Posted in various departments in the hospital on a monthly rotation: Gastroenterology, Oncology, Nephrology, Respiratory Medicine, Cardiology, Cardio Thoracic and Vascular Surgery, General Surgery, Orthopedics, Neurology, General Medicine, Pediatrics, Psychiatry
- Monitored drug regimens for dose adjustments, performed cost effective analysis and checked for medication errors.
- Reporting: Adverse drug reactions, drug interactions and contraindications.
- Drug Information Center: Provided drug and poison information, medical devices assistance to patients and health care professionals.
- Antibiotic Stewardship: Participated in data collection and analysis of antibiotic usage in the hospital and developed an optimal plan to improve the prescription pattern of antibiotics.
- Prescription audit: Collection of data, analysis, and presentation of the plan to avoid prescription errors.
- Crash cart audit: Audited the crash cart in various wards to ensure the functioning and stock of items as required by the institution guidelines.
- Patient Counseling: Provided counseling to patients on the importance of adherence to medications, medication safety, instructions on medical device usage and lifestyle modifications.
- Collaborated with interdisciplinary healthcare team to optimize patient outcomes through coordinated care plans.
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, MA12.2023
Doctor of Pharmacy (PharmD) -
The Tamil Nadu Dr. M.G.R Medical University
India12.2019
Skills
- Global Regulatory Compliance
- GLP and GCP Compliance
- International Regulatory Affairs
- Pharmaceutical industry knowledge
- Regulatory Policies
- Document Control
- Regulatory Submissions
- Clinical Trials Oversight
- Labeling and Packaging
- Virtify eCTD
- International Regulations
- ISO Standards and FDA regulations
- CAPA Management
- Technical Documentation
- Change Control Processes
- Information Verification
- GMP Auditing
- Clinical Trials Protocols
- Research and Audits
- Sound quality management techniques
Certification
- Doctor of Pharmacy, Reg.No:736/A, Tamil Nadu Pharmacy Council, India, 07/2021
- Attended university accredited Continuing Medical Education programs (CME), 2019
- Attended twelve university accredited Continuing Pharmacy Education programs (CPE), 2017 - 2019
Research Experience
PUBLICATIONS
• Affordability, availability, and tolerability of anti-seizure medications are better predictors of adherence than beliefs: Changing paradigms from a low resource setting.
Seizure: European Journal of Epilepsy 83(2020)208-215.
• Alteration in renal function following loop diuretics in patients with acute decompensated heart failure.
Asian Journal of Pharmaceutical and Clinical Research Vol 12, Issue 12, 2019,1-3.
PAPERS PRESENTED
• ‘Alteration in renal function following loop diuretics in patients with acute decompensated heart failure’, 4th International Conference on Clinical Pharmacy, Manipal College of Pharmaceutical Sciences, India. Jan 2019
• Poster presentation on Chemotherapy Awareness, PSG Super Specialty Hospitals, India. Feb 2018
Academic Projects
Northeastern University, Boston, MA 09/2021 - 12/2023
• Informed Consent form: Designed an informed consent form as per 21 CFR part 50(b).
• Case studies: Falsified Medicines and Electronic Cigarettes in the EU: Political Economy and Product Regulation.
• Drafted: Pre-NDA Meeting Request, FDA Form 2252, FDA Form 356h, Safety Labeling Changes.
• Framed a new protocol to an open IND and submitted an annual report to an open IND.
• Biopharmaceutical Quality Management System (QMS) Requirements: Submission Plan and Quality Manual.
• Prepared an integrated summary of safety (ISS) and integrated summary of effectiveness (ISE) for a new drug.
• Group Projects: Team Leader:
i. Prepared Table of Contents (TOC) for a Clinical Study Report (CSR) in eCTD format.
ii. Prepared an SOP in eCTD format.
iii. Prepared an IND in eCTD format.
Extracurricular Activities
- Organized the Regulatory Affairs Digital Council Summit, Indegene, NJ 2023
- Volunteered and organized the 3rd Annual Rejuvenation and Conference, PSG Heart Valve Forum, India 2018
- Educated the public through social awareness programs conducted by Revised National Tuberculosis Control Programme, India 2018
- Organized a national conference on “Current perspectives in novel drug delivery systems, PSG Super Specialty Hospitals, India 2017
- Participated in National Service Scheme (NSS) program conducted in rural areas to educate the public on infectious diseases and public health 2014
Timeline
Capstone Project
Boehringer Ingelheim Pharmaceuticals Inc
09.2023 - 12.2023
Regulatory Affairs Intern
Indegene Inc
12.2022 - 07.2023
Experiential Learning (XN) Project Intern
Ebb & Flo
07.2022 - 09.2022
Clinical Pharmacist Intern
PSG Super Specialty Hospitals
12.2018 - 12.2019
Master of Science - Regulatory Affairs
Northeastern University
Doctor of Pharmacy (PharmD) -
The Tamil Nadu Dr. M.G.R Medical University
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