Leela Kalyani Martha
Regulatory & Quality Specialist @Glenmark Pharmaceuticals
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WORK HISTORY
Regulatory & Quality Specialist @Glenmark Pharmaceuticals
Allentown, PA, US
Prepared, reviewed, and maintained regulatory submissions (IND, NDA, ANDA) and supporting documentation in compliance with FDA, EMA, ICH, and global regulatory requirements, ensuring accuracy, completeness, and timely submission to health authorities. · Supported submission lifecycle activities, including amendments, annual reports, and responses to health authority inquiries. · Utilized regulatory systems (Veeva Vault, Track Wise, eCTD Viewer, SharePoint, EDMS, Master Control) to manage document control, supporting the full submission lifecycle including initial filings, amendments, and regulatory responses. · Supported CMC regulatory activities by preparing, reviewing, and maintaining CMC documentation for regulatory submissions, ensuring CTD Module 3 content was accurate, compliant, and aligned with FDA and international regulatory standards. · Contributed to CMC sections of IND submissions, protocol amendments, annual reports, and responses to health authority information requests by coordinating data, reviewing documentation, and ensuring timely submission readiness and compliance. · Collaborated with Quality, Manufacturing, and Technical Operations teams to collect, verify, and organize CMC information, supporting product lifecycle management, while maintaining regulatory compliance, documentation consistency across programs. · Monitored and interpreted evolving FDA, EMA, and ICH regulations, guidance documents, and industry standards, assessing potential impacts on regulatory strategies and supporting compliance across product development and post-market activities. · Supported cross-functional teams by providing regulatory guidance on development, manufacturing, quality, and change management activities, facilitating compliance and regulatory readiness for submissions · Assisted in the development, revision, and implementation of SOPs, work instructions, and quality documentation to strengthen QMS effectiveness.
EDUCATION
Northeastern University
Master of Science, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
Andhra University
Bachelor's degree, B. Pharmacy
Andhra University
Bachelor of Pharmacy
Northeastern University
Master's degree, Regulatory Affairs
ABOUT LEELA KALYANI MARTHA
A recent graduate with a Master of Science degree in Regulatory Affairs from Northeastern University. I interned at 4D Molecular Therapeutics from January 2024 to June 2024, I actively worked towards several key goals that deepened my understanding of regulatory affairs and drug development. I was involved in regulatory assistance for the IND application of product 4D-175, where I ensured precise compliance with regulatory processes. My responsibilities included drafting and updating regulatory documents, managing citations and references, and preparing documents for final review and submission.I also contributed to various regulatory submissions, including DSURs, annual reports, and ODD applications. My work involved conducting in-depth research on regulatory trends and interpreting FDA guidance to ensure our submissions met all necessary requirements.This experience has sharpened my skills in regulatory compliance and team collaboration while igniting my interest in drug lifecycle management. My strengths include effective communication, quick learning, attention to detail, and a self-driven approach. I excel in time management, overseeing projects, and meeting deadlines consistently.I am passionate about integrating scientific knowledge with regulatory and legal insights to ensure the safety and efficacy of pharmaceuticals. My goal is to continue expanding my expertise in regulatory processes to contribute to the development of safe and effective therapies.
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