Provide strategic guidance and regulatory support for both clinical and non-clinical activities within the regulatory sub-team, cross-functional teams, and external vendors/contractors. Present and align with stakeholders and senior management for tactical regulatory strategies, including submission strategies and timelines. Directly reported to the SVP of Regulatory Affairs.

Define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects, including Rare Disease. Provide strategic and tactical advice to cross-functional teams –e.g., within regulatory sub-teams, clinical development, R&D, commercial, medical affairs– to achieve timely and efficient development and maintenance of the program, while ensuring compliance with applicable regulatory requirements.

Manage a large diverse team of subject matter experts (SMEs) with a goal of developing and commercializing orphan drug products. Responsible for development programs related to drug substances, drug products, and medical devices, such as injection systems, implants, connected devices, novel technologies, and diagnostics. Accountable for ensuring the translation of product strategy into clear and actionable development plans and deliverables. Accountable for CMC and device contents agency submissions.Started at Shire in April 2018, and the company was later acquired by Takeda in 2019.

- Device Technical Expert and Device Engineering Lab lead for parenteral solution and suspension diabetes products- Led and executed product modification design, fixture designs, test method development, technical transfers, qualifications/validations, and complex complaint investigations, for the existing combination products and new upcoming products - Conducted and managed product deviations investigation, root cause analysis, and institute corrective and preventative action implementations, and regulatory responses timely and effective- Managed and served as subject matter expert the DHF, DMR, risk assessment, and risk management documents for the combination products- Led product specification changes and communicated results with internal and external teams- Led AZ’s Parenteral Center of Excellence and communicated with the AZ Global Device Teams; collaborated closely with cross-functional teams, i.e., site teams, global teams, and suppliers- Mentored/coached/trained new team members and co-ops to conduct GXP Device Engineering Lab tasks

-Group and Technical Lead for four major projects; three in Tangential Flow Filtration (TFF) and one for a single-use membrane chromatography scaling deviceComplex TFF Projects:-Development of composite ultrafiltration membrane with pore size suited to the application based on separation by size-Incorporate the membrane in four device formats of different area. -Development of processes to fabricate device that includes the membrane Single-Use membrane chromatography:-Development of single-use membrane adsorber scaling device for separation of biomolecules based on charge or affinity-Hands on with: 3D modeling, generating prototypes for initial customer or internal evaluation, molding machines (injection molding); planning and executing membrane casting trials at production scale-Developed products within a formal stage gate process on a manufacturing equipment in a cGMP facility/environment-Worked with project leads from different departments – e.g., corporate and plant quality, marketing, manufacturing, procurement, and validation teams-Supervised and mentored Engineers, technicians, operators in R&D and manufacturing-Communicated project status and results through formal presentations and reviews to the team and business management

-Developed automated system for defined nanofibrous scaffold architecture for tissueregeneration-Characterized mechanical behavior of nanofibrous structure by using mechanical testing machine (DMA/Instron), AFM, and environmental SEM (ESEM)-Functionalized biodegradable polymeric scaffolds with extracellular molecules for tissue regeneration-Designed components for a cyto-mechanical loader to apply uniaxial and biaxial strains to cells cultured in 2 to 3 dimensional scaffolds-Developed polymeric nanofibrous structure with nano-filler particles incorporation for nanoheaters applications-Developed novel composite and rolled nanofibrous scaffolds for tenogenesis of stem cells, and nanofibrous surgical sponge from cellulose and alginate.-Mentored and supervised graduate and undergraduate student research assistants-For Adjunct Professor Position (Fall semester 2009 at UMass Lowell): Taught Mechanical Behavior of Materials (sophomore and junior level students - 90 Students)

-Developed and conducted a broad range of experiments and tests for materials characterization and processing of fibers, fabrics, and composites. For example, (1) for nanofibers project: developed technique for controlled nanofiber architectures –aligned, patterned, and twisted yarn–, investigated mechanical behavior of nanfibrous scaffolds with different architectures, and gained knowledge of cell medium, differentiation systems, pellet culture, and cell seeding in 3D systems; and (2) for coated fabrics: Investigated mechanical deformation of airbag fabrics –sponsored by Delphi Corp (Troy, MI)-Mentored/supervised graduate and undergraduate research assistants -Managed several projects, working directly with corporate sponsors on tight deadlines and with multi-institutional collaborators on complex projects-Coordinated research activities and results with different institutes-Generated annual reports required for the sponsor and coordinated activities with the collaborators

Coated Fabrics: -Studied effect of coated fabric construction on mechanical behavior – sponsored by National Textile Center (NTC)-Investigated mechanical behavior of rubber-reinforced fabrics for instant shelters – US Army Natick Soldier Center (Natick MA)-Generated annual reports required for the sponsor (NTC) and coordinated activities with the collaborators – UMass Lowell Plastics Eng Dept., UMass Dartmouth, Georgia Tech, and U. California Davis-This body of work led to lead authorship in a book chapter in Smart Textile Coatings and Laminates (see Book Chapters)-Made multiple presentations at external conferences.Composites:-Mechanical behavior of composite flywheels – Beacon Power (Wilmington, MA)-Mechanical behavior of aerogel blankets – sponsored by Aspen Aerogel (Northborough, MA)Nanofibers:-Assembled an electrospinning setup to investigated the effect of electric field on nanofibers

-Developed unique test fixtures and specialized tests for implants and biologic tissues -Determined mechanical properties and fatigue resistance of materials, medical implants, and biologic tissues-Generated and maintained documentation required for new design fixture and assigned tasks