Harish Bhapkar
Group Lead, Regulatory Affairs Professional with 15 Yrs. Experience in CMC & Clinical Co-authoring, Scientific editing, document & submission publishing and Life Cycle Management of the various Regulatory Submissions
- Role
- Group Lead, Global Regulatory Affairs at Eli Lilly and Company
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Harish Bhapkar
With over 15 years of experience, I lead the CMC Post-Approval Regulatory Associates Team at Eli Lilly and Company, specializing in project planning, team building, and coaching. My responsibilities include resourcing, goal setting, performance management, capacity planning, and submission direction, alongside fostering collaboration with stakeholders to enhance process efficiency and customer satisfaction. My expertise lies in regulatory affairs, including submission management, dossier compilation, and document publishing for global markets. Dedicated to process development and team mentoring, I actively contribute to strategic execution and process improvements to support successful regulatory outcomes for the organization.
Experience
Group Lead, Global Regulatory Affairs
May 2021 — Present · Bengaluru, IN
Leadership Experience• Led CMC Pre-Approval Regulatory Associates Team • Currently, leading a CMC Post-Approval Regulatory Associates Team • Involvement in resourcing, development planning, goal setting, performance management, workload allocation, capacity planning, training, mentoring, feedback, coaching, and submission direction.• Lead business strategy and execution meetings, administrative tasks, and change control.• Collaborate effectively with colleagues and stakeholders, focusing on customer satisfaction through process development and implementation.• Engage with the Quality Team for process improvements and deviation management, continuously learning from business partners and colleagues, and providing technical insights for submission management. and monitor the regulation/external environment as appropriate• Represented the CMC Editing team during a management visit.Technical Experience• Expert in Regulatory Affairs: in Clinical and CMC submissions, regulatory strategy execution, dossier authoring/co-authoring, formatting, scientific editing, document publishing, and quality review across submissions ((IND, DSUR, CTA, MAA, BLA, RTQs, Annual Reports, Variations, Site Registration, Product and Site Renewals, YBPR), ensuring compliance with local regulatory requirements.• Author, edit, publish, and manage CMC regulatory documents.• Proficient in eCTD and non-eCTD submissions and SME for CMC guides and checklists. • M1 Document Procurement - CPP, Declarations, Validation Reports, GMP Certificates, LOA-DMF, LOA-SMF, MFG Authorization, COAs. etc• M2, and M3, M5 Documents Compilation, ICF, SAP, CSR-Synopsis, CSRs, QOS, DMF, SMF, DS, DP, Appendices, Regional.ETC• Expert in Submission workflow management for US and EU eCTD, NeeS, and Paper• Optimized workflows, resolved issues, and integrated with Adobe, Clinical Vault, and RIM
Education
Catalyst Delhi
Post Graduate Diploma in Clinical Research, Clinical/Medical Laboratory Science/Research and Allied Professions
Pune University
M.Pharmacy (Pharmacology)
2007 — 2009
Pune Board
SSC
1999 — 2000
Pune University
Bachelor of Pharmacy (B.Pharm.)
2002 — 2006
SP Jain School of Global Management - Dubai, Mumbai, Singapore & Sydney
PROFESSIONAL CERTIFICATION IN ADVANCED PROJECT MANAGEMENT & STRATEGIC LEADERSHIP
Pune Board
HSC
2001 — 2002
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