Vijay Maheshwari
Associate Director - Cell Therapy @百时美施贵宝
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WORK HISTORY
Associate Director - Cell Therapy @百时美施贵宝
Hyderabad, IN
Represent regulatory CMC and lead matrix team for cell therapy pipeline products and commercial products through completion of post-marketing commitments and relevant lifecycle management.Independent provider strategic guidance related to current regulatory requirements and expectations for cell therapy marketing applications, IND/IMPD or life cycle management.Interface with HA for CMC submissions and CMC specific issues, with guidance and oversight from supervisor on complex topics.Interpret global regulation and guidance. Identify regulatory opportunities and risks.Review and provide regulatory assessments of change controls and deviations.Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategic documents.Manage relationships with diverse teams.
EDUCATION
National Institute of Pharmaceutical Education and Research - Ahmedabad
Master of Science - MS, Pharmacy
Tolani Institute Of Pharmacy (Diploma), Adipur 417
D. Pharm, Pharmacy
SIGMA INSTITUTE OF PHARMACY, BAKROL 261
Bachelor of Pharmacy - BPharm, Pharmacy
SKILLS
ABOUT VIJAY MAHESHWARI
Currently managing/supporting development and post approval CMC regulatory submissions & strategy for novel Cell Therapy (CAR-T) products for developed markets at BMS India.14 years of experience & proven track record in Biosimilar Regulatory Submissions in US, EU, CA, ROW and Indian Markets.Expertise from regulatory perspective on cell line development & characterization, process development & characterization, control strategy, virus validation, pharmaceutical development, aseptic sterilization validation, process and product comparability, combination product, stability and analytical similarity. Experience and thorough understanding of biosimilar stage specific regulatory requirements including IND, IMPD, Pre-BLA meetings, BLA, MAA & Post Approval Product Lifecycle. Practical experience in CMC writing, review, publishing and submission management of IND, IMPD, BLAs & MAAs for Biosimilar therapeutic proteins and monoclonal antibodies.Successfully received approvals of multiple filed Biosimilars BLAs & MAA in US and EU respectively.Achievement in Biosimilar Lifecycle Management: Multiple Post Approvals variations submission and approvals for DS & DP Scale Up, DS and DP Site change, New/Duplicate DP Filling Line addition, Analytical Site Transfer, Changes in analytical procedures including others.Managed regulatory support in multiple GMP Inspections US-FDA and EMA Audits.Extensive experience in Change Control Review and Management System.Highly skilled in interpretation of Regulations and Guidance for Biosimilars in FDA, EU, CA & Other Developed and Global Regions. Expertise in Documentum Management System (D2 & DCM), Lorenz Docubridge, TrackWise System, Microsoft office tools.Experienced in compiling Biosimilar Product Development meeting packages and presentations for initial and life cycle management interactions with Agencies, including comparability protocol submissions. Co-ordinated and managed colleagues for timely delivery of assigned task, and provided guidance and training sessions on regulatory requirements for initial and life cycle management activities.Gathered good expertise in ICH, FDA, EMA and HC guidelines on biosimilar product development, registration and life cycle management.Managed RCGM, local FDCA and DCGI filings for multiple domestic biosimilar product submissions from clone to MAA stage in Domestic Market (India).
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