Shibu Baburaj
Director Global Regulatory Affairs Cmc @Organon
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WORK HISTORY
Director Global Regulatory Affairs Cmc @Organon
Plymouth Meeting, PA, US
Lead Biologics CMC Team and develop and execute the regulatory affairs/CMC strategy to support the projects/products, provide strategic and scientific support, interact with manufacturing and quality groups, regulatory agencies, contract and partner organizations, provide assessment of impact on products and interface with international affiliates on regional regulatory strategy and implementation plans.
EDUCATION
Jamia Hamdard
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
Jamia Hamdard
Master of Pharmacy - MPharm, Pharmaceutics, Pharmaceutical Technology, Industrial Pharmacy, Drug Design, NDDS
SKILLS
ABOUT SHIBU BABURAJ
At Organon, my leadership in Global Regulatory Affairs CMC focuses on pioneering regulatory strategies for biologics. Our team has successfully navigated the complexities of global healthcare compliance, establishing a reputation for excellence in strategic regulatory execution. We have fostered collaborative partnerships with manufacturing, quality groups, and international agencies to maintain product integrity and market alignment.With proficiency in GxP guidelines and a comprehensive understanding of quality\'s role in clinical development, our cross-functional endeavors have yielded a robust framework for regulatory submissions. This has empowered Organon to uphold its dedication to safety and innovation within the healthcare sector, reinforcing our commitment to delivering outstanding patient care worldwide.
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