Mansi Rai
Associate Scientist i @Baxter International Inc.
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WORK HISTORY
Associate Scientist i @Baxter International Inc.
Ahmedabad, IN
Specialized in the technical and regulatory stewardship of marketed pharmaceutical products. Focused on maintaining the post-approval lifecycle, ensuring all products meet global regulatory requirements and quality standards. Expert at translating technical manufacturing changes into compliant regulatory strategies to ensure uninterrupted patient access to essential therapies. Regulatory Stewardship: Manage the post-approval lifecycle for a diverse product portfolio, ensuring continuous alignment with FDA, EMA, and ICH global standards.Change Control Management: Lead technical impact assessments for manufacturing and analytical changes, defining filing strategies to maintain global compliance.
EDUCATION
Bbdniit
B pharm
Banasthali Vidyapith
M Pharm, Pharmaceutics
ABOUT MANSI RAI
I’m a Formulation Development Research Associate specializing in injectable dosage forms with over 4 years of hands-on experience in pharmaceutical R&D at Endo India PAR Formulations Pvt. Ltd.My expertise spans pre-formulation studies, formulation optimization, stability studies (ICH Q1A), and regulatory documentation (ANDA/NDA) for parenteral products. I take pride in combining a strong foundation in pharmaceutics with practical exposure to cGMP, QbD, and technology transfer processes that ensure robust, compliant, and efficient product development.I’ve contributed to multiple parenteral formulation projects, assisting in dossier preparation and optimizing formulation parameters to enhance product stability and yield. I enjoy working in cross-functional teams and using data-driven approaches to solve formulation challenges.Currently based in Mumbai, I’m open to opportunities in Formulation and Development (Injectables) roles where I can continue contributing to innovative pharmaceutical solutions and regulatory success.
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