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Navneet Kaur, a seasoned Senior Manager in Regulatory Affairs, embarked on her journey driven by a deep passion for science and a commitment to improving patient health. Her academic foundation includes a Bachelor’s and Master’s in Chemistry (Honors) from Guru Nanak Dev University, an M.S. in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, and over a decade of rigorous training in compliance and regulatory practices. She has built a career that seamlessly blends technical expertise with strategic decision-making. Kaur’s extensive experience spans multiple markets, including the United States, Europe, Canada, Australia, and Brazil, making her an asset in navigating the global regulatory environment.
“Every product represents hope for countless patients, and it’s my job to navigate the intricate regulatory pathways, specifically in chemistry manufacturing and controls to make that hope a reality,” Navneet shares.
Understanding the Risks
Spending the early years of her professional life in quality and compliance, Kaur gained a profound understanding of the high stakes involved when quality, safety, and efficacy do not meet the required standards. With an average of over 1,284 drugs recalled annually, the pharmaceutical industry demands vigilance. Quality control issues, ranging from incorrect labeling to contamination, can result in costly recalls, regulatory fines, and reputational damage.
Thankfully, there are many ways to prevent these setbacks, particularly through audits and regulatory inspections. A quality management system helps identify potential issues before they escalate, ensuring compliance with regulations and maintaining the safety and efficacy of pharmaceutical products. Regular audits also help catch discrepancies early, reducing the risk of significant financial and operational impacts​​.
The Power of Prevention
Preventing setbacks is paramount, and Kaur recognizes the importance of audits and regulatory inspections. A strong quality management system not only identifies potential issues early but also ensures compliance with regulations while maintaining the safety and efficacy of pharmaceutical products. Regular audits catch discrepancies, mitigating financial and operational risks. Kaur’s expertise in this area has been instrumental in safeguarding the integrity of numerous pharmaceutical products.
From Quality Control to Regulatory Mastery
Kaur started her professional journey at Ultra-Chiron Pharmaceuticals as a quality control analyst, where she developed her skills in product testing, on-the-floor quality assurance, drug product reviews, and compliance. At Parabolic Drugs Ltd., she played a pivotal role in establishing a stability testing laboratory for Active Pharmaceutical Ingredients (APIs), ensuring compliance with ICH guidelines. As a quality assurance officer at Ranbaxy Laboratories Ltd. (now Sun Pharmaceuticals Ltd.), Kaur managed deviations, conducted root cause analyses, implemented corrective and preventive actions (CAPAs), and collaborated with various departments to ensure adherence to regulatory standards.
Global Regulatory Prowess
Kaur’s move to the United States further solidified her regulatory expertise. At Sanofi Genzyme, she provided critical support for a remediation project, reviewing, assessing, and approving key documentation required to comply with FDA expectations. Hired as a Corrective and Preventive Actions (CAPA) expert, she addressed critical non-compliance issues for a pharmaceutical company in Cambridge, MA. She thoroughly assessed the vendor management system and prepared efficient processes to ensure the organization’s continued success. Her ability to review and approve crucial documentation—from Master Batch Records and deviations to analytical data and defining successful CAPAs—demonstrated her capacity to handle complex compliance issues effectively.
She began her journey in regulatory affairs as an Associate, progressing to Senior Regulatory Affairs Associate at Johnson Matthey Pharmaceutical Services (now Veranova). At the Devens site in Massachusetts, she was pivotal in managing regulatory activities, developing submission strategies for drug substances supporting Investigational New Drug (IND) applications, and Abbreviated New Drug Applications (ANDAs). Her expertise extended to authoring and reviewing Module 3 documentation for drug substances, Drug Master Files (DMFs), and Active Substance Master Files (ASMFs), preparing comprehensive risk assessments, and ensuring compliance with evolving regulatory requirements—managed amendments and life cycle for all the products.
Her proficiency in navigating the complex regulatory landscape ensured timely, high-quality submissions. Among her notable achievements, she successfully prepared and submitted drug substance dossiers for an oncology generic product to both the FDA and Brazil’s health authorities, leading to approvals in both markets and facilitating access to affordable oncology treatments. Additionally, she prepared and submitted a Drug Master File (DMF) dossier to Health Canada for a cardiovascular drug, which received approval and has since made a meaningful impact on patient care.
Kaur has obtained Certificates of Pharmaceutical Products (CPP) for various countries on behalf of a prominent pharmaceutical client. A CPP, issued by the regulatory authority in the exporting country, serves to confirm that a pharmaceutical product adheres to rigorous quality, safety, and efficacy standards. This document is essential for the legal importation and distribution of medications in foreign markets, ensuring compliance with international drug manufacturing and distribution regulations while facilitating the global flow of quality-assured pharmaceuticals.
Furthermore, Kaur has applied her extensive knowledge of the International Council for Harmonization (ICH) Q3D guidelines to conduct thorough risk assessments for multiple products. These assessments have critically evaluated the necessity for additional control strategies to ensure that elemental impurities (EIs) adhere to the Permitted Daily Exposure (PDE) limits, thereby reinforcing product safety and ensuring regulatory compliance.
Driving Excellence at Alkermes Inc.
In her current role at Alkermes Inc., Kaur continues to drive regulatory excellence. She collaborates with internal partners to develop regulatory Chemistry Manufacturing and Controls (CMC) strategies, preparing comprehensive clinical trial applications (CTAs), INDs and IMPDs (Investigational Medicinal Product Dossier). Her responsibilities extend to assessing, classifying, and performing regulatory impacts on the drug product changes. Her strategic mindset ensures that regulatory risks are identified early, safeguarding development projects. She is proficient in managing the CMC lifecycle.
The Future of Regulatory Affairs
As the pharmaceutical industry evolves, regulatory affairs professionals like Navneet Kaur are becoming increasingly vital. Her strategic approach, meticulous attention to detail, and ability to navigate complex regulations make her an invaluable asset. Kaur’s journey serves as an inspiration for aspiring regulatory professionals, highlighting the importance of strategic thinking, continuous learning, and a commitment to excellence.
In an industry where the stakes are high and the margin for error is slim, Kaur stands out as a leader who consistently delivers regulatory excellence. Her capacity to prevent setbacks, navigate global regulations, and foster a collaborative environment ensures that pharmaceutical products meet the highest standards of quality, safety, and efficacy. As the industry looks to the future, professionals like Kaur will continue to shape the regulatory landscape and safeguard patient health and well-being worldwide.
