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

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.
• 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

Master Of Pharmacy, Medicinal And Pharmaceutical Chemistry

Bachelor Of Pharmacy - Bpharm, Pharmacy

Education record