Ritika Tripathi Email and Phone Number

• Global Regulatory Operations Team Lead for Regulatory Management of Change• Assessment, planning, and leading execution of projects for any operational changes that have a regulatory impact on company’s “Right to sell”• Regulatory Compliance• Provide regulatory strategy and actionable guidance on global change management• Hiring, Team development, Performance Management • Process optimization, workload distribution, assessment, and asset management

Process lead for highly efficient Regulatory Management of Change Team.Ensure FMC’s right to sell pesticide products globally through management of change process Maintain/establish consistency between manufacturing and registration – What is manufactured is what is soldResponsible for Process improvements activities, improve team performances and bringing innovation with changing demands.End to end project management with multiple objectives and changing demands.Liaising with various stakeholders, including but not limited to country managers, supply chain, global regulatory teams, manufacturing sites, third party sites, marketing and business team and R&D teams.Designing, implementing and managing projects on a global scale for implementing supply chain strategies of regulatory impact.Ensuring that project deliverables are on time and with required level of quality

My role as part of the Regulatory Input to Operations Team (RIO) is to ensure DuPont’s right to sell pesticide products globally through management of change driven by supply chain. To work on and support any changes and updates to supply chain and sourcing which impact registrations globally, by, but not limited to, preparing documents of all supply chain driven changes, communicating to all countries impacted, compiling and preparing all necessary registration documentation required to submit to local authorities, ensuring submissions are made to all impacted regulatory agencies and to finally track all approvals. Also, reviewing and providing a regulatory assessment for all QARs (quality approval requests) documenting supply chain changes. • Consulting with global registration managers, technology leaders, operations black belts, supply chain managers and other operations staff on supply chain issues which may impact registrations.

Registration support to Asia Pacific Countries to bring about commercialisation, Import Registration, Label Expansion or renewal/Re-registration of various Crop Protection products Resolving queries pertaining to Registration and Regulatory processProviding timely and appropriate solution to roadblocks in registration to countriesLink between Global teams and Regional teamsCollaborate with other regional processes (GRS, RIO etc.) for seamless information flow and holistic supportTo be updated about various changes, updates in the dynamic world of regulatory and registration frameworkTo be informed about various changes brought about supply chain/regulatory changes that necessitates registration changes

• Providing high-level administrative support involving efficient handling of top & confidential correspondence, management of document flow, attending visitors & directing various queries to relevant departments • Coordinate with Field Development Managers for data collection etc. • Payment of all the bills relating to Technology Leader’s office & maintaining the copies • Prepare TERs / MRFs • Ensuring authenticity of data and releasing payments • Tracking budget on monthly basis & expenses data for the R&D group • Vendor Payment management • Keep track of all AMC and contract renewals

• Preparing of dossiers for submission to the Central Insecticide board, Ministry of Agriculture.• To prepare replies to deficiencies reported by the CIB.• To do research work related to Toxicology.• Digitization of all the records.• Preparing related reports.

Communication with the CRO/ Sponsor and PI for smooth start up and running of the trail till close out.Communication with CRO/Sponsor and PI for Signing of Clinical Trial Agreement.Documents submission to Ethics committee for Approval and notification.Patient Recruitment and Follow - upEnsuring protocol Compliance at Site according to ICH - GCP and Schedule YTrial - Related Documents Maintenance and Close Out.

NEUROLOGY and PSYCHIATRY Trials.Have experience in handling various phase III and phase II trials in indications such as Epilepsy, MS, PD, Low Back Pain, Alzheimer's and Schizophrenia.Design and maintain process to conduct study accurately and in compliance with GCPEnsure safety of study subjects.Reporting of AE's to investigator and follow up.Filling of CRF and eCRF for study accurately, completely and in timely manner.Maintain all required documentation in study documentation file.Drug dispensation and Drug Accountability Communication with Ethics committee regarding approval and notification of study Activities.Handling Monitoring Visits on site.Date Query ResolutionAssisting PI with patient visit at site.Have handled Sponsor Audit.

CRC- Maintenance of Study Documents, Source, SMF, CRF Filling, Query Resolution, Accountability of IP, IP Dispensation, handling monitoring visits, reporting of AEs and follow up, conducting patient visit at site.Feasibility of upcoming studies, coordinating with EC, EC submissions etc.

Some of my work responsibilities were: Site reorganization• Site Feasibility checklist preparation• Site selection• PSSV,SSV,SEV• Conducting Monitoring vists at site.• Ethics committee submissions and approvals • Managing documents such as CRF, SMF, and Source.• Filling of CRF and eCRF• Drug dispensation • Drug accountability • Managing essential documents• Site Evaluation• CRA responsibilities• Site Close Out