Provided
Navneet Kaur, a seasoned Senior Supervisor in Regulatory Affairs, launched into her journey pushed by a deep ardour for science and a dedication to bettering affected person well being. Her tutorial basis features a Bachelor’s and Grasp’s in Chemistry (Honors) from Guru Nanak Dev College, an M.S. in Regulatory Affairs for Medicine, Biologics, and Medical Units from Northeastern College, and over a decade of rigorous coaching in compliance and regulatory practices. She has constructed a profession that seamlessly blends technical experience with strategic decision-making. Kaur’s intensive expertise spans a number of markets, together with the US, Europe, Canada, Australia, and Brazil, making her an asset in navigating the worldwide regulatory surroundings.
“Each product represents hope for numerous sufferers, and it is my job to navigate the intricate regulatory pathways, particularly in chemistry manufacturing and controls to make that hope a actuality,” Navneet shares.
Understanding the Dangers
Spending the early years of her skilled life in high quality and compliance, Kaur gained a profound understanding of the excessive stakes concerned when high quality, security, and efficacy don’t meet the required requirements. With a mean of over 1,284 medication recalled yearly, the pharmaceutical business calls for vigilance. High quality management points, starting from incorrect labeling to contamination, can lead to expensive recollects, regulatory fines, and reputational injury.
Fortunately, there are a lot of methods to stop these setbacks, notably by audits and regulatory inspections. A top quality administration system helps establish potential points earlier than they escalate, making certain compliance with laws and sustaining the protection and efficacy of pharmaceutical merchandise. Common audits additionally assist catch discrepancies early, lowering the chance of great monetary and operational impacts.
The Energy of Prevention
Stopping setbacks is paramount, and Kaur acknowledges the significance of audits and regulatory inspections. A powerful high quality administration system not solely identifies potential points early but in addition ensures compliance with laws whereas sustaining the protection and efficacy of pharmaceutical merchandise. Common audits catch discrepancies, mitigating monetary and operational dangers. Kaur’s experience on this space has been instrumental in safeguarding the integrity of quite a few pharmaceutical merchandise.
From High quality Management to Regulatory Mastery
Kaur began her skilled journey at Extremely-Chiron Prescription drugs as a high quality management analyst, the place she developed her expertise in product testing, on-the-floor high quality assurance, drug product critiques, and compliance. At Parabolic Medicine Ltd., she performed a pivotal function in establishing a stability testing laboratory for Lively Pharmaceutical Substances (APIs), making certain compliance with ICH tips. As a high quality assurance officer at Ranbaxy Laboratories Ltd. (now Solar Prescription drugs Ltd.), Kaur managed deviations, performed root trigger analyses, carried out corrective and preventive actions (CAPAs), and collaborated with varied departments to make sure adherence to regulatory requirements.
World Regulatory Prowess
Kaur’s transfer to the US additional solidified her regulatory experience. At Sanofi Genzyme, she supplied vital assist for a remediation challenge, reviewing, assessing, and approving key documentation required to adjust to FDA expectations. Employed as a Corrective and Preventive Actions (CAPA) skilled, she addressed vital non-compliance points for a pharmaceutical firm in Cambridge, MA. She totally assessed the seller administration system and ready environment friendly processes to make sure the group’s continued success. Her means to evaluation and approve essential documentation—from Grasp Batch Data and deviations to analytical knowledge and defining profitable CAPAs—demonstrated her capability to deal with complicated compliance points successfully.
She started her journey in regulatory affairs as an Affiliate, progressing to Senior Regulatory Affairs Affiliate at Johnson Matthey Pharmaceutical Companies (now Veranova). On the Devens website in Massachusetts, she was pivotal in managing regulatory actions, growing submission methods for drug substances supporting Investigational New Drug (IND) purposes, and Abbreviated New Drug Functions (ANDAs). Her experience prolonged to authoring and reviewing Module 3 documentation for drug substances, Drug Grasp Information (DMFs), and Lively Substance Grasp Information (ASMFs), getting ready complete danger assessments, and making certain compliance with evolving regulatory necessities—managed amendments and life cycle for all of the merchandise.
Her proficiency in navigating the complicated regulatory panorama ensured well timed, high-quality submissions. Amongst her notable achievements, she efficiently ready and submitted drug substance dossiers for an oncology generic product to each the FDA and Brazil’s well being authorities, resulting in approvals in each markets and facilitating entry to inexpensive oncology therapies. Moreover, she ready and submitted a Drug Grasp File (DMF) file to Well being Canada for a cardiovascular drug, which acquired approval and has since made a significant impression on affected person care.
Kaur has obtained Certificates of Pharmaceutical Merchandise (CPP) for varied nations on behalf of a outstanding pharmaceutical consumer. A CPP, issued by the regulatory authority within the exporting nation, serves to substantiate {that a} pharmaceutical product adheres to rigorous high quality, security, and efficacy requirements. This doc is crucial for the authorized importation and distribution of medicines in overseas markets, making certain compliance with worldwide drug manufacturing and distribution laws whereas facilitating the worldwide circulation of quality-assured prescription drugs.
Moreover, Kaur has utilized her intensive data of the Worldwide Council for Harmonization (ICH) Q3D tips to conduct thorough danger assessments for a number of merchandise. These assessments have critically evaluated the need for extra management methods to make sure that elemental impurities (EIs) adhere to the Permitted Day by day Publicity (PDE) limits, thereby reinforcing product security and making certain regulatory compliance.
Driving Excellence at Alkermes Inc.
In her present function at Alkermes Inc., Kaur continues to drive regulatory excellence. She collaborates with inside companions to develop regulatory Chemistry Manufacturing and Controls (CMC) methods, getting ready complete scientific trial purposes (CTAs), INDs and IMPDs (Investigational Medicinal Product File). Her duties lengthen to assessing, classifying, and performing regulatory impacts on the drug product adjustments. Her strategic mindset ensures that regulatory dangers are recognized early, safeguarding improvement tasks. She is proficient in managing the CMC lifecycle.
The Way forward for Regulatory Affairs
Because the pharmaceutical business evolves, regulatory affairs professionals like Navneet Kaur have gotten more and more important. Her strategic method, meticulous consideration to element, and skill to navigate complicated laws make her a useful asset. Kaur’s journey serves as an inspiration for aspiring regulatory professionals, highlighting the significance of strategic pondering, steady studying, and a dedication to excellence.
In an business the place the stakes are excessive and the margin for error is slim, Kaur stands out as a pacesetter who constantly delivers regulatory excellence. Her capability to stop setbacks, navigate international laws, and foster a collaborative surroundings ensures that pharmaceutical merchandise meet the best requirements of high quality, security, and efficacy. Because the business appears to the longer term, professionals like Kaur will proceed to form the regulatory panorama and safeguard affected person well being and well-being worldwide.
