Harika Bodala

Regulatory Affairs & Quality focused professional with specialized training in pharmaceuticals, natural health products, and global regulatory frameworks

Talent

MiltonMember since August 25, 2026

Preparation and review of regulatory submissions (NDS, ANDS, CTA, DIN applicatioHealth Canada, FDA, EMA regulatory frameworksICH-GCP principles and clinical trial regulatory complianceGMP compliance, audits, and SOP adherenceProcess validation & technology transfer requirementsHealth Canada labeling regulations for drugs, biologics, and NHPsCAPA (Corrective and Preventive Actions)Deviation investigations and documentationGood Documentation Practices (GDP)Writing clear, compliant regulatory documents and summariesPreclinical and clinical trial phases and documentation needsBasic knowledge of electronic submissions (eCTD)Great Attention to DetailStrong Time Management SkillsCritical & Problem-Solving SkillsAdaptabilityCross-Functional CollaborationClear written and verbal correspondence with regulators and colleaguesManaging multiple projects and documents simultaneouslyMaintaining confidentiality and integrity in all tasksQuickly acquiring and applying new regulatory knowledgeMicrosoft WordExcelPowerPointOutlookAdobe Acrobat for PDF regulatory formsDocument management systems (DMS)

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About

Regulatory Affairs & Quality focused professional with specialized training in pharmaceuticals, natural health products, and global regulatory frameworks. Currently completing a Post-Graduate Diploma in Regulatory Affairs at AAPS, with hands-on experience preparing CMC dossier sections, reviewing labeling requirements, and ensuring compliance with Health Canada, FDA, and EMA guidelines. I am detail-oriented, compliance-driven, and genuinely interested in pharmaceutical manufacturing and Natural Health Product environments.

Experience

Pharmacy Technician - Medicine Shoppe Pharmacy - Winnipeg, MB

(2023-02 - 2025-11)

Processed incoming medication orders, counted, and labeled prescriptions with high accuracy and efficiency in accordance with pharmacy policies and Health Canada industry regulations.
Utilized electronic database systems (Kroll) to input precise data entry profiles, ensuring a 98% error-free verification rate under strict GxP operational guidelines.
Managed the pharmacy inventory tracking, ensuring proper stocking and verification of expiry metrics for controlled substances and narcotics.
Collaborated with pharmacists and healthcare professionals to resolve prescription discrepancies and maintain audit-ready daily registries under strict PIPEDA privacy guidelines.

Quality Analyst - Hetero Drugs Limited - Hyderabad, India

(2018-01 - 2020-11)

Administered comprehensive quality assurance reviews over commercial processing lines, ensuring all materials and final technical data packages met strict international specifications.
Spearheaded internal quality self-inspection programs, cataloging operational variances and producing compliance reports to maintain permanent site readiness for health authorities.
Verified raw data records, certificates of analysis (CoA), and manufacturing batch logs prior to quality release routing.
Enforced strict facility adherence to cGMP guidelines by monitoring documentation workflows and evaluating personnel training modules to minimize operational non-compliance.

Research & Development (R&D) Analyst - Dr. Reddy's Laboratories - Hyderabad, India

(2013-03 - 2016-10)

Led root-cause investigations alongside cross-functional QC and plant production personnel to resolve unexpected analytical testing and chemical contamination anomalies, deploying CAPA strategies.
Authored and revised high-stakes technical documents, standard operating procedures (SOPs), working guidelines, and Batch Manufacturing Records (BMR) to enforce rigid compliance and remove processing ambiguities.
Facilitated the seamless technical transfer of optimized manufacturing methodologies and critical parameter data packages from benchtop R&D laboratories to commercial scale-up production units.
Maintained laboratory infrastructure and instrument logs under strict cGLP/cGMP parameters, immediately documenting out-of-specification (OOS) trends to support product integrity.

Education

Post Graduate Diploma - Clinical Research, Pharmacovigilance and Regulatory Affairs (CRPRA) - Academy of Applied Pharmaceutical Sciences (AAPS) (2026-09)

PG DIPLOMA - Pharmacy Technician - NBCC (2024)

Bachelor of Pharmacy - B.Pharm - Osmania University (2007)