Regulatory Affairs Data Integrity

BHAGYASHREE SHIVAJI BHOINE

857-***-**** *******************@*****.*** Linkedin

SUMMARY Detail-oriented Regulatory Affairs graduate student with a solid foundation in Pharmacy and hands-on experience in GMP, quality control

(QC), and microbiology. Proven ability to support equipment qualification, environmental monitoring, and documentation practices aligned with 21 CFR Part 11 and EU GMP. Strong interest in QA compliance, data integrity, and continuous improvement in pharmaceutical operations.

SKILLS Strong background in GMP compliance, data integrity (ALCOA+), environmental monitoring, and CAPA/deviation handling. Familiar with qualification/validation support, GDP, CMC review, and regulatory inspection readiness. Efficient in time management and MS Office tools, with a team-oriented approach.

EDUCATION Northeastern University June 2026

Master of Science in Regulatory Affairs GPA - 3.9 / 4.0 Poona College of Pharmacy BVDU May 2023

Bachelor of Pharmacy GPA - 7.90 / 10.00

PROJECTS Thesis: Insight of Next Generation Sequencing (NGS): Pharma Application, Strength & Benefit Jan 2022 - June 2022 Poona College of Pharmacy Pune, India

• Explored applications of NGS in precision medicine and pharmacogenomics. Evaluated sequencing methods (Illumina, SMRT, etc.) for clinical research utility. Assessed NGS's impact on drug discovery and regulatory science. Real-World Evidence (RWE) for FDA Drug Approvals January 2025 - March 2025 Northeastern University Boston, MA

• Assessed how RWE supports post-market safety surveillance. I studied FDA guidance on data quality, study design, and regulatory submission. Focused on compliance risks related to poor data integrity and bias in observational studies. FDA Regulation of Off-Label Promotion & QA Risk Controls April 2025 – June 2025 Northeastern University Boston, MA

• Analyzed FDA enforcement against misleading drug promotion. Reviewed internal audit practices and corporate integrity agreements. Emphasized QA protocols to prevent promotional violations and mitigate compliance risk. EXPERIENCE Internship Trainee June 2022 – July 2022

NuLife Pharmaceuticals Pune, India

• Supported sample testing, documentation, and adherence to production standards.

• Assisted in preparing materials for audits and maintaining compliance logs. Internship Student February 2022 - May 2022

FDA Approved Public Laboratory Pune, India

• Conducted microbial limit testing and EM under supervision.

• Documented observations in line with GDP and data integrity norms.

• Supported qualification and calibration tracking. Internship Trainer Dec 2021 – Jan 2022

T. Walker's Pharmaceuticals Pune, India

• Participated in internal audits and documentation review for QA readiness.

• Collaborated with QA staff to monitor SOP compliance and update logs.

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