Saniia Shchinar, MS

Lead regulatory submissions and lifecycle management for the US, European Union, and Hong Kong markets. Develop and implement regional regulatory strategies to support product registrations, post-approval activities, and compliant advertising and promotional (ad promo) initiatives. Collaborate cross-functionally with CMC, Clinical, Medical, and Commercial teams, including participation in MLR review processes, to ensure timely and compliant submissions and promotional materials. Provide regulatory guidance for advertising and promotional (ad promo) materials and product labeling to ensure adherence to regional requirements and alignment with approved labeling.

Lead regulatory activities for pharmaceutical products across US and international markets. Develop and implement regulatory strategies aligned with FDA, EMA, and ICH guidelines. Collaborate with cross-functional teams to support customer regulatory needs and drive product compliance. Prepare, review, and maintain technical documentation, including regulatory dossiers and change controls. Serve as subject matter expert on regulatory trends, standards, and best practices.

Built a successful regulatory consulting firm from the ground up, providing regulatory affairs and pharmacovigilance services across Asia, North America and Europe. Secured regulatory approvals for more than 200 pharmaceutical products in multiple regions, helping clients expand market access and grow their businesses. Developed customized regulatory strategies, reducing time to market by optimizing submission processes and ensuring compliance with local and international standards. Provided technical documentation and dossier preparation for complex products, including biologics and drug delivery systems, ensuring adherence to evolving regulations. Trained and mentored clients and internal teams on regulatory requirements, improving compliance readiness and operational efficiency. Established strong partnerships with health authorities and industry stakeholders, enabling faster resolution of regulatory challenges. Conducted regulatory intelligence assessments, providing clients with competitive insights and strategic recommendations for market expansion.

Managed registration and market approval for over 50 medicines, medical devices, and medical equipment in Kyrgyzstan, ensuring compliance with national and international regulatory standards. Led end-to-end regulatory submission processes, reducing approval timelines by 40% through improved coordination with health authorities and optimizing documentation quality. Implemented a pharmacovigilance system, improving product safety monitoring and compliance with local safety reporting requirements. Negotiated successfully with regulatory bodies, achieving faster approval for high-priority products and resolving complex regulatory challenges. Developed and reviewed technical dossiers and labeling documents, ensuring compliance with current regulatory guidelines. Collaborated with cross-functional teams, including manufacturing, quality assurance, and marketing, to support product launches and lifecycle management. Provided regulatory training and support to internal teams, increasing regulatory compliance awareness across the organization.

Conducted innovative research on utilizing breast tissue as a targeted drug reservoir. Specialized in developing transdermal drug delivery systems, focusing on incorporating anticancer drugs into solid lipid nanoparticles. Further enhanced drug delivery efficiency by integrating these nanoparticles into microneedles. Passionate about leveraging nanotechnology for more effective and targeted cancer treatments.

During this program, I gained a strong foundation in pharmaceutical sciences, including pharmacology, medicinal chemistry, and pharmaceutical technology. The curriculum emphasized drug formulation, pharmacokinetics, and the regulatory aspects of pharmaceuticals. Practical training included compounding, quality control, and drug safety. I developed expertise in pharmaceutical care, drug interactions, and patient counseling, while also gaining insight into the pharmaceutical industry and regulatory practices.