Regulatory Program Manager at Global Regulatory Partners (GRP) (2026-02 – Present)
- Lead end-to-end regulatory projects and programs from planning phase, through execution phase till closure.
- Develop project plans, project trackers of deliverables, risk mitigation strategies, and timelines for each project.
- Monitoring of project deadlines.
- Host internal team meetings and client updates.
- Escalate key risks and scope deviations.
- Manage disaster escalation.
- Interface with Quality, Manufacturing, Supply chain, and external vendors.
- Leading project charters, scope planning, resource allocation, and SOW finalization.
- Collaborating with external CDMOs and internal cross-functional teams to ensure timely execution.
- Served as primary contact for client communication, milestone tracking, and escalation handling.
- Identify areas for operations improvement and contribute to SOPs.
Senior Manager – Project Management at Acme Generics Pvt. Ltd. (2024-08 – 2026-02)
- Directing multiple site transfer and CMO-driven projects for OSD products in regulated markets (US).
- Leading project charters, scope planning, resource allocation, and SOW finalization.
- Presentations and management of monthly reports on status of each project to the senior management.
- Coordinate regulatory submissions and ensure the availability of filing documents as per the checklist.
- Track and monitor the completion of deliverables (Gantt chart) and pending actions with client and internal project team.
- Collaborating with external CDMOs and internal cross-functional teams to ensure timely execution.
- Acting as project SPOC for client communication, budget & milestone tracking, and escalation handling.
Senior Manager – International Drug Regulatory Affairs at Curiza Life Sciences Pvt. Ltd. (2021-11 – 2024-07)
- Managed a portfolio of site transfer and ANDA projects, ensuring on-time execution and regulatory compliance.
- Monitoring of project deliverables against the scope, timelines, quality, and budget targets.
- Developed and tracked project plans, timelines, action logs, and milestone dashboards to monitor progress and identify delays early.
- Supported tech transfer, scale-up, validation, and commercialization activities for manufacturing programs.
- Management of reference dossier and associated project documents, creating a structured document repository that improved retrieval time and reduced document-related queries during project reviews.
- Assisted in preparation and review of project documentation, including trackers, meeting minutes, risk registers, and status report.
- Regularly coordination with the cross-functional teams across QA, QC, manufacturing, supply chain, regulatory and CMOs for the timely execution of the deliverables.
Manager – Project Management at Acme Generics Ltd. (2019-03 – 2021-10)
- Oversaw end-to-end development and project execution for OSD products, focusing on tech transfer and submission readiness.
- Facilitated stakeholder meetings and reviewed QMS actions relevant to project delivery and compliance.
- Ensure the organized availability of site transfer documents and proper storage for future references.
- Coordinated with internal team (QA/ QC/ Manufacturing/ Supply chain/ R&D/ Licensing etc) and external vendors, laboratories and logistics partners to support on-time delivery of materials, samples, and documentation.
- Ensure availability of resources viz. RM/ PM/ Change parts/ Tooling/ Analytical consumables/ licenses well in advance for the timely initiation of the project execution.
- Monthly project status to management (MIS), timely escalation of issues for management support.
- Maintained ownership of milestone delivery, tracking of milestone payments, project documentation, and client engagement.
Research Scientist – Drug Regulatory Affairs at Jubilant Generics Ltd. (2015-11 – 2019-02)
- Contributed to post-approval lifecycle management, supplement filings, and product change documentation.
- Coordinated with internal teams to meet submission timelines and support launch readiness.
- Ownership of site transfer projects execution and submission phases.
- Served as the primary point of contact between internal stakeholders (Site team), client, regulatory team to maintain alignment on deliverables and milestones.
Officer – Quality Assurance at Cipla Ltd. (2014-12 – 2015-10)
- Supported QA deliverables during tech transfers and OSD product readiness.
- Reviewed deviations, CAPAs, and regulatory-related documentation for internal audits and external compliance.
Officer – Quality Assurance at Glenmark Generics Ltd. (2011-07 – 2014-11)
- Reviewed and managed documentation supporting site transfer and commercial manufacturing of OSD products.
- Provided QA input on validation protocols and supported document readiness for EU and US filings.
Regulatory Affairs Associate at Lupin Ltd. (2009-10 – 2011-06)
- Supported compilation of technical data, batch records, and analytical reports for OSD filings.
- Ensured compliance with regulatory commitments during project changes and submissions.
Sales & Marketing at Nicholas Piramal India Ltd. (2005-04 – 2008-01)
Sales & Marketing at Emcure Pharmaceuticals (2004-10 – 2005-03)
