Neha Malhotra
Regulatory Affair Coordinator @Nanz Pharma
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WORK HISTORY
Regulatory Affair Coordinator @Nanz Pharma
Pickering, ON, CA
Coordinated regulatory submissions and responses to authorities, ensuring timely processing of NHP/VHP/CTD dossiers and cosmetics notifications, aligning with site activation timelines.• Reviewed literature and prepared safety/efficacy reports, maintaining accurate trial-related documentation and GDP compliance.• Supported SOP development, gap assessments, and monthly reviews, reconciling findings and escalating risks to project leads.• Communicate effectively with stakeholders.• Support development of regulatory strategies and assist RA Manager in gap assessments for regulatory compliance.• Prepare and participate in monthly management review meetings.• Ensure Good Documentation Practices (GDP) and record accuracy.• Assist with ad hoc projects as requested.
EDUCATION
Punjabi University, Patiala
Bachelor of Pharmacy - BPharm, Pharmacy
Academy of Applied Pharmaceutical Sciences
Postgraduate diploma, Clinical Research, Pharmacovigilance, and Regulatory Affairs
Punjabi University, Patiala
Master's degree of Pharmacy, Pharmaceutics and Drug Design
ABOUT NEHA MALHOTRA
Pharmacovigilance and Medical Writing professional with over 8.4 years of global experience in drug safety, aggregate report writing, and regulatory submissions across diverse therapeutic areas including oncology, immunology, autoimmune, hematology, cardiovascular, and dermatology. I also bring 5.5 years of pharmaceutical R&D experience, developing solid oral dosage forms for US, EU, and Asian markets, which strengthens my understanding of the complete drug development lifecycle.Currently based in Canada, I work as a contractor from Zenith PV, embedded within the safety team of a globally recognized pharmaceutical company, contributing to aggregate safety reporting, risk management plans (RMPs), signal management, and Health Authority interactions. This role has given me hands-on Canadian regulatory experience and extensive collaboration with cross functional teams, ensuring compliance with ICH, GVP, FDA, and Health Canada guidelines.I have previously contributed to leading CROs such as Parexel and IQVIA, authoring and managing over 250 aggregate reports including PBRERs, PSURs, DSURs, PADERs, ICSRs, clinical narratives, HA responses, and SOP development. I thrive in cross-functional teams, mentoring colleagues, and delivering high-quality, timely documentation.Passionate about enhancing drug safety and regulatory compliance, I am eager to leverage my expertise to support innovative therapies and multinational pharmaceutical clients.Let’s connect if you are looking for a professional with proven expertise in global pharmacovigilance, regulatory medical writing, and Canadian safety reporting.
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