As the direct report to the Senior Vice President of the Manufacturing Division, I actively contributed to strategic planning and the development of new capabilities. I spearheaded operational excellence initiatives utilizing lean-six sigma methodologies to enhance delivery performance and achieve cost savings. In my role as the Program Technical Lead for a commercial manufacturing program at Zoetis, I successfully oversaw its execution. Additionally, I provided valuable regulatory affairs support to clients, assisting them in designing product development and regulatory submission strategies. As a member of the core team, I actively participated in making crucial Quality and Regulatory decisions.Currently leading a site integration team as a project manager for multimodal facility acquisition worth USD 85 million. • Regulatory strategy and submissions for DNA, mRNA, and drug-device products.• Core team member for Quality and Regulatory affairs and audits.• Program Technical Lead for Zoetis' commercial manufacturing program.• Ensured regulatory compliance with BLA/MAA procedures.• Identified new capability areas and prepared investment business cases.• Obtained USFDA advice for GMP facility design.• Led cross-functional teams to improve processes and reduce failures as part of Lean Six Sigma initiatives.• Reviewed clinical trial and marketing authorization applications. Throughout, I emphasized regulatory compliance, strategic planning, collaboration, and process improvement, achieving success in the biopharmaceutical industry.

As the Head of Regulatory Affairs, Medical Device, and Intellectual Property Management division, I reported directly to the Chief Operating Officer (COO). My role involved coordinating with the R&D, manufacturing, and business development teams to develop and execute product development and commercialization strategies.Key Responsibilities:• Developed comprehensive product development and commercialization strategies for medical devices and therapeutic proteins, considering both CMC (Chemistry, Manufacturing, and Controls) and clinical aspects.• Served as the program manager for an insulin analogue, overseeing its development and successful implementation.Achievements:• Successfully established the medical device division, which involved key tasks such as creating a compelling business case, selecting development partners, conducting testing, setting up manufacturing facilities, and conducting human factor studies.• Engaged in multiple interactions with regulatory bodies including the USFDA, EMA (European Medicines Agency), and Health Canada to align biosimilar product and medical device development strategies.• Attained the CE mark for a reusable pen and accomplished a successful ISO 13485 audit, demonstrating compliance with international quality management system requirements.In my role, I exhibited expertise in regulatory affairs, medical device development, and strategic planning, ultimately contributing to the success of product development and commercialization initiatives.

As a member of the team reporting to the Senior Vice President and Head of Biologics Program, I played a key role in leading the development and registration strategies for biosimilar products across multiple regions, including the EU, US, LATAM, and ASEAN countries. In addition, I supported the business development team by interacting with clients.Key Achievements:• Successfully managed the global phase-I and phase-III contract research organization (CRO) selection process, overseeing a budget of $20 million.• Provided complete oversight of the phase-III clinical trial, including activities such as investigator meetings, site management, obtaining country-specific clinical trial approvals, and developing and validating bioanalytical methods.• Accomplished the successful completion of the phase-III clinical trial and subsequent submission of the Marketing Authorization Application for the EU.• Collaborated with the Quality groups to establish robust GMP (Good Manufacturing Practice) systems, resulting in positive outcomes during audits.Through my contributions, I demonstrated strong leadership, project management, and regulatory expertise in the biologics field.

As a leader of the regulatory team, I successfully guided the approval process for an Investigational New Drug (IND) in the US, Investigational Medicinal Product Dossier (IMPD) in the EU, and provided support in the submission of a clinical trial application in Japan for a biosimilar product. I engaged in interactions with regulatory agencies in the EU and US to facilitate the development of biosimilar molecules.Additionally, I played a key role in preparing product development and registration strategies, encompassing both CMC (Chemistry, Manufacturing, and Controls) and clinical aspects. These strategies were tailored for the EU, US, and major emerging market countries, and involved active collaboration with business partners.Furthermore, I contributed to the review and approval of Quality Management System documents, ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the product development process.

As a core team member, I contributed to the product development process, specifically focusing on the CMC (Chemistry, Manufacturing, and Controls) aspects for the EU market. I actively engaged with partners throughout the development process to ensure effective collaboration.Additionally, I served as a project manager, overseeing the planning and execution of project strategies for CMC deliverables, particularly for microbial origin products, including fusion proteins. I utilized tools such as MS-Project to efficiently plan and manage resources, as well as to track the progress of projects.Through my role, I demonstrated strong project management skills, a deep understanding of CMC requirements, and effective communication and coordination with partners to drive successful product development.

I possess extensive experience in managing the complete product life cycle, encompassing various stages such as technology acquisition, purification process development, process characterization (including risk analysis and Design of Experiments), process scale-up, technology transfer, and validation of recombinant products.Furthermore, I have successfully established product development roadmaps utilizing Quality by Design (QbD) principles, ensuring a systematic and science-based approach to product development.Additionally, I have achieved success in transferring technology for a commercial manufacturing process to an international client, effectively facilitating the implementation of the process in their facilities.