Mohit Gupta Email & Phone Number

Irvine, Ca, Us

California, United States

As Head of US Strategic Development, Pharmacovigilance & Regulatory Affairs at Vizen Life Sciences, I am responsible for advancing strategic growth and regulatory innovation in the US pharmacovigilance market. Vizen Life Sciences is a global leader in comprehensive drug safety solutions, supporting top-tier pharmaceutical and biotech companies with services ranging from individual case safety reporting to advanced risk management and regulatory compliance.At Vizen, I work alongside a talented team of over 180 professionals—including physicians, pharmacists, and medical writers—who use state-of-the-art AI technology to streamline case processing, signal detection, and safety data exchange. Together, we are dedicated to delivering high-quality drug safety services that uphold the highest standards of patient care and regulatory excellence.

Irvine, California, United States

• Led the development of the innovation pipeline, introducing variations in existing products to enhance the injectable drug portfolio. Prioritized and executed selected programs to accelerate pipeline progression.• Oversaw a cross-functional innovation team, managing formulation/chemistry, analytical, and packaging development. Evaluated external products, technologies, and selected CMOs to enhance internal innovations.

United States (California, New Jersey, Florida, Etc.)

• Specialized in multiple dosage forms, encompassing sterile, solid oral (hormonal & non-hormonal) products, liquid orals, semi-solids, injectables, topicals, ophthalmic, etc. • Proficient in both small and large molecule development, including monoclonal antibodies, compliance remediation (483, Warning Letter, Consent Decree, Audit, etc.), systems scaling for operational efficiency, and implementation of lean manufacturing principles and achieving operational excellence (Six Sigma Green Belt).• Notable achievements include leading the successful launch of a mAB product for a $20B public biotechnology company, overseeing product development and process improvement for a 505(b)(2) private pharmaceutical company, and directing site technical groups for a $1.7B public pharmaceutical company.

Corona, California, United States

• Led the Pharmaceutical Technology site groups across seven North America and Asia sites of legacy Actavis. Provided comprehensive technical, strategic, and tactical guidance for various initiatives, including new product development, technology transfers, process and cleaning validation, PAT implementation, and operational excellence programs.• Responsible for network optimization, site selections – internal and external, PT organization restructuring, budgeting, strategic guidance, technology transfers, compliance support, remediation of products and process, risk management of new product launches, marketed product support, process and cleaning validation programs & new technology.• Originally at Watson Pharmaceuticals, which eventually became Actavis, Allergan, and Teva

Corona, California, United States

• Leader of Pharmaceutical Technology, Site Project Management and Compliance Remediation (Product, Process and Computer). • Provide technical, strategic and tactical guidance for Technology Transfers, New Product Development, Process and Cleaning Validation, Operational Excellence program and Compliance Remediation projects for process, product and Part 11.

Corona, California, United States

• Successfully made transformational changes and led the creation of a comprehensive improvement program which delivered tangible operational & financial performance improvements. • Significantly reduced cost by over 50%, improved efficiencies and reduced write-offs by leveraging systematic problem solving approach.

Corona, California, United States

• Supervised the validation group responsible for process/cleaning validations, process investigations and manufacturing support.• Originally at Watson Pharmaceuticals, which eventually became Actavis, Allergan, and Teva

Detroit, Michigan, United States

• Established and supervised R&D group responsible for product development, technology transfers and process validations of over 25 pharmaceutical products for US markets.

New Delhi, Delhi, India

• Supervised the product development groups responsible for developing products for American, European, Australian and other world markets.

Master'S Degree, Pharmacy And Pharmaceutics

Bachelor'S Degree, Pharmacy

Six Sigma Green Belt, Operational Excellence

Postgraduate Diploma, Business Administration

Dual Certificate, Medical Devices And Pharmaceuticals

Gamp 5, Principles Of Computerized Systems Compliance