Kalpana Reddy Munnangi.
Consultant (Regulatory Project Management & Technical Writing) - Regcmc (Cell and Gene Therapy) @Bristol Myers Squibb
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WORK HISTORY
Consultant (Regulatory Project Management & Technical Writing) - Regcmc (Cell and Gene Therapy) @Bristol Myers Squibb
Seattle, WA, US
Overseeing logistical planning and establishing timelines for drafting scientific and regulatory content at various stages of CMC submissions and responses to health authority requests- Engaging with external suppliers when required for CTD content development and review processes- Assisting in dossier compilation and maintain adherence to system compliance standards for regulatory submissions- Providing guidance and scientific oversight in the creation of modules 2.3 and 3 content- Collaborating with subject matter experts within CTDO to identify source documentation and coordinate timely delivery of approved technical materials that meet CTD requirements and regulatory objectives- Authoring scientific content for CTD Quality sections, ensuring alignment with regulatory strategies across clinical, commercial, and life-cycle CMC submissions- Preparing responses to health authority queries supported by comprehensive technical reports- Review, address feedback, facilitate comment resolution processes, and revise draft sections, as necessary- Ensuring clarity, accuracy, and consistency throughout all dossier messaging- Mentoring and training team members on best practices in technical writing and procedural compliance.
EDUCATION
Dr. MGR Medical University
Master of Pharmacy, Pharmaceutical Analysis
Acharya Nagarjuna University
Bachelor of Pharmacy, Pharmacy
SKILLS
ABOUT KALPANA REDDY MUNNANGI.
Senior Regulatory Affairs leader with over 12 years of industry experience supporting the development of small molecules, and Cell & Gene therapy products through various phases of development including pre-clinical, clinical, initial commercial submission, and post-approval phases. Qualifications and achievements include- RAC (US) certified- Successful submissions of investigational new Drug applications (INDs) and clinical trial applications (CTAs) in the US, EU, UK, Japan, and Canada- Supported original marketing applications in the USA (BLA), and managed post-approval submissions- Leading regulatory agency interactions and meeting preparations- Expertise in CAR-T cell therapies, and gene therapies- Ability to monitor and analyze the current regulatory environment using regulatory intelligence to develop regulatory strategy.
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