Regulatory Affairs Professional | 6+ Years of Experience in Global Regulatory Publishing & Submissions Management. Experienced in managing and publishing global regulatory submissions, including INDs, BLAs, NDAs, MAAs, and NDSs, for the US, EU, and Health Canada. Proficient in eCTD publishing, optimizing submission processes, and ensuring compliance with cGMP, GLP, and GCP standards. Adept at supporting the regulatory lifecycle of drug products, facilitating efficient product development while maintaining high-quality regulatory standards.

submissions management. My expertise includes planning, editing, formatting, and publishing regulatory submissions for small molecules, biologics, Ophthalmics, radiopharmaceuticals, and cell and gene therapies. I have extensive experience in eCTD submissions and lifecycle management, having prepared and submitted regulatory filings such as INDs, NDAs, BLAs, MAAs, CTAs, ANDAs, DMFs, and promotional material submissions to OPDP via FDA Form 2253. I specialize in publishing documents across all eCTD modules using tools like Veeva Vault and Lorenz Docubridge, ensuring quality control and compliance. Additionally, I manage IND maintenance submissions, including SUSARs, annual reports, and amendments, while coordinating timely responses to health authority queries. My technical proficiency includes working with regulatory and content management systems such as Veeva Vault, Lorenz Docubridge, RIM, and Global Submit, along with expertise in document formatting, publishing tools, and regulatory databases. With strong analytical, problem-solving, and communication skills, I contribute to streamlining regulatory processes and ensuring compliance with global regulatory guidelines.