MANEESHA BONDU
Boston,MA
Summary
Dynamic Quality and Regulatory Associate at Propharmex with expertise in regulatory submissions and risk management. Successfully led FDA inspections with minimal findings, enhancing compliance through strategic policy development. Proven adaptability and collaboration skills, driving timely submissions and improving data management systems for optimal product lifecycle management.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Quality and Regulatory Associate
Propharmex
01.2022 - 08.2023
- Conducted thorough benefit-risk assessments for product portfolio, guiding decision-making around product lifecycle management strategies.
- Led initiatives to optimize data management systems, improving data retrieval efficiency by 40% and reducing reporting errors by 25%.
- Collaborated with cross-functional teams to ensure the timely submission of high-quality regulatory documents.
- Enhanced regulatory compliance by developing and implementing detailed policies and procedures.
- Streamlined the regulatory submission process, cutting average approval timelines by 20% and accelerating product time-to-market.
- Improved regulatory inspection readiness by conducting quarterly internal audits, resolving 95% of identified gaps within 30 days.
- Maintained and archived regulatory paperwork.
- Developed or tracked quality metrics.
Quality Assurance Intern
Propharmaex
08.2021 - 05.2022
- Demonstrated adaptability when faced with shifting priorities or unexpected challenges, always maintaining focus on delivering high-quality results.
- Prepared and submitted over 30 QA evaluation reports to management, directly supporting batch release and decision-making processes.
- Determined overall product quality by conducting and evaluating 100+ QA tests per month, ensuring a 98% batch release success rate.
- Facilitated team knowledge sharing through bi-weekly presentations and SOP walkthroughs, improving QA team efficiency by 20% as measured by reduced error rates.
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, MA06-2025
Skills
- Regulatory research
- Regulatory research
- Document review
- Policy analysis
- Regulatory submissions
- Risk management
- Audits
- International regulations
- Document control
- FDA regulations
- SAP EHS management
- ISO standards
Accomplishments
- Reduced deviation closure time by 25% by implementing a streamlined tracking and escalation system.
- Reviewed and approved GMP records, including CAPAs, deviations, and change controls.
Certification
- GCP for Clinical Trials with Investigational Drugs and Medical Devices, CITI - 6/05/2025 - 6/05/2026.
- Six Sigma White Belt, C.S.S.C - 5/11/2025
- Good Manufacturing Practices, PharmUni - 03/04/2025 - 03/04/2027
- Good Clinical Practice, NIDA Clinical Trial Network - 11/14/2023 - 11/14/2025
Timeline
Quality and Regulatory Associate
Propharmex
01.2022 - 08.2023
Quality Assurance Intern
Propharmaex
08.2021 - 05.2022
Master of Science - Regulatory Affairs
Northeastern University
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