Onkar Pawar Email & Phone Number

Mexico City, Mexico

• Working closely with customers & offshore accounts on multiple RFPs to engage with new & existing opportunities• Working cohesively with the pre-sales and global customers in contract management, resource management, project planning, and budgeting in LATAM region• Working closely with global partners in recruitment, training, managing, and delivery operations• Working closely with the customers in creating SLA metrics, issue escalation plan and governance structure• Responsible for creating, maintaining and assuming accountability for a culture of high customer service and ensuring delivery of service meets or exceeds Service Level Agreements• Working closely with the client in creating SLA metrics, issue escalation plan and governance structure• Working closely with global partners in recruitment, trainings, managing and retaining delivery resources

Mexico City Area, Mexico

• Monitored customer quality metrics and took proactive steps to implement resolutions and restore acceptable levels for a US & LATAM based Pharmaceutical client• Span of control of more than 20+ team members both in India and in Mexico• Providing thought leadership to the Submission Publishing, PV and Medical review teams• Responsible for the financial growth of the project• Work closely with the robotic automation and transformation teams to implement process improvements• Close governance with the customer on strategic decisions as well as daily deliverables

Mumbai Area, India

• Regulatory Submission Publishing in eCTD, Non-eCTD , Paper and eDOK formats for US, EU, CH, APAC, GCC and other ROW regions and dispatch to the HA via e-submission gateways and to the Sponsor’s Affiliates.​• Provided support for all Original Filings and Subsequent Variations(EU) and Amendments(USA) and its delivery right through the portal US FDA or EMA or via the SDA Link to Regulatory Liaisons/CRAs.​

Mumbai-Delhi

• Performing document level publishing i.e. Compliance checking, hyperlinking (internal and external), Bookmarking, TOC, Fast Web View, QC/ review of documents, Rendering Multiple Documents to PDF • Ensuring PDF standards that to be comply with ICH and FDA recommendations• Responsible for assembly, compilation and dispatch of US FDA, EMA in eCTD format• Publishing activities (Compilation of application as per submission planner, publishing of eCTD, to various Agencies)Experience on tools like Adobe Acrobat Professional IX, X, XI, LORENZ DocuBridge® 5.2, , ISI Tool Box 6.2.0, LORENZ eValidator™ • Onsite support, development and troubleshooting of Trackwise, Documentum and Extedo• Assist in data migration activities for fresh filings for various regions/countries -Europe, ASEAN, LATAM, Africa• Assist in data migration activities for post approval(renewals/variations) for various regions/countries -Europe, ASEAN,LATAM, Africa• Assist in data migration activities for API DMF/CEP• Liaise with internal and external clients in the tracking and status update of project plans• Liaise with global team to support global projects• Assist in dossier preparation for Europe and emerging markets

Master Of Pharmacy, Medicinal And Pharmaceutical Chemistry

Bachelor Of Pharmacy - Bpharm, Pharmacy

Education record