Aysha Rana

Led expertise in ICH CTD/ACTD registration dossier preparation (20) and compilation for Pharmaceuticals, Biologicals, Nutraceuticals, and Medical Devices, ensuring successful product registrations. Ensured strict compliance with regulations and standards set by DRAP, MHRA, WHO, PIC/S, USFDA, EMA, PMDA, ISO, ICH, and ISPE guidelines, maintaining a high level of quality assurance across all operational aspects. Negotiated with regulatory authorities, developed Regulatory Strategies, analyzed scientific and legal documents, and maintained comprehensive knowledge of company product ranges for strategic alignment with business objectives. Gathered and reported adverse drug reactions, prepared PSURs, and managed all Pharmacovigilance activities for proactive risk management. Managed operational requirements, conducted risk management, provided expertise during audits and inspections, monitored regulatory changes, and oversaw documentation management for efficient organizational processes.

Stayed updated on regulatory legislation changes, delineating labeling, storage, and packaging requirements to maintain product integrity. Prepared and compiled documents for registration renewal and submission (25) to regulatory authorities for continued market access. Developed and executed regulatory strategies to facilitate product development, approval, and market access, including submissions to regulatory agencies leading to commercialization of products in target markets. Compiled and documented adverse drug reactions, prepared Periodic Safety Update Reports (PSURs), and managed all Pharmacovigilance tasks for the safe monitoring of products. Demonstrated expertise in developing ICH CTD registration dossiers for Pharmaceuticals to facilitate the approval process.

Successfully secured product registrations (40) in diverse regions including DRAP, Cambodia, Kyrgyzstan, Tajikistan, Uzbekistan, Afghanistan, Myanmar, Maldives, Cameroon, and Iraq, showcasing proficiency in international market access. Collaborated with R&D, manufacturing, quality, and marketing teams to maintain regulatory compliance across the product lifecycle. Supported regulatory audits and inspections, rectifying findings, and implementing corrective actions, maintaining high-quality standards in operations. Monitored and assessed adverse events, ensuring prompt reporting to regulatory authorities in accordance with guidelines, thereby upholding patient safety.

Achieved successful business development and product registrations (90) for Common Technical Document (CTD) dossiers across a wide range of regions, including DRAP, WHO, Vietnam, Sri Lanka, Philippines, Mongolia, Uganda, Kyrgyzstan, Tajikistan, Uzbekistan, Jordan, DR Congo, Kenya, Rwanda, Tanzania, Sudan, Ghana, Nigeria, and Yemen, demonstrating a comprehensive understanding of global regulatory requirements. Managed the preparation of inspection-related documents for domestic and international markets, including PIC/S, contributing to successful inspections and regulatory approvals across diverse markets. Secured WHO (World Health Organization) dossier approval for Levofloxacin tablets, enabling market access and product availability in multiple countries. Developed and implemented regulatory Standard Operating Procedures (SOPs), leading to streamlined processes in regulatory affairs operations. Led the implementation of a Pharmacovigilance system within the company for the first time, enhancing patient safety across product portfolios.