Ramkumar Dubey, Ph.D. Email & Phone Number

Mumbai, Maharashtra, India

Directly managing the team of 10 members

India

Act as a Global Regulatory Lead (GRL) Primary accountable for managing multiple projects/CMC programs of various complexities, managing and ensuring daily delivery of regulatory and strategic activities.Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized Initial submission and post approval changes in collaboration with CMC GRL.Author and /or compiles Regulatory Strategy Documents including Quality overall summary and submission of package globally i.e., M2, M3 S/P/R (NDA, NDS, MAA, ANDA etc.)Provide CMC guidance support to update RRM and review the content of RRM.Review of Initial submission and variation package and authorized it for the assigned product.Use of Regulatory system and management of CMC documentation (Pfizer’s GDMS, PEARL, Trackwise, PDM, Rosetta etc.)Key achievement:Global Product lead for assigned OSD drug product family for finalizing the filing strategies, Approval of Package (initial, variation, renewal & annual report) and coordinate across the Pfizer for regulatory compliance.SME for Analytical development, PDR, query response and post approval changes.Core Member for LRP (Local Regional Product) Team for Global Harmonization to access the documents acroos Pfizer (EuCANZ)Promoted from Deputy Manager to Manager within a short period of time.

Hyderabad Area, India

Reporting to Senior Vice President- Global Regulatory Affairs-Responsible for preparation of ANDA, AND & MAA (M2 & M3) and review of complete ANDA (M1, M2, M3 & M5).-Technical evaluation and clearance of pre-development/development activities (Control correspondence, biowaiver, specifications (APIs, excipients, Packaging material & Finished Drug Products), packaging plan/pack selection, stability protocol, dissolution protocol, MFR/MPR etc.).-Technical review of post EB documents for dossier compilation [BMR & BPR (Exhibit and Intended), PVP, PVR, Change Control, Bill of Material (BOM), Stability data & Post approval protocol and commitment].- Overall responsible for review of all analytical related documents and their clearance (Analytical method validation/transfer protocol & report for Assay, related substances, Dissolution & Forced degradation study)- Over all responsible for Regulatory Intelligence, Training & Strategy for global (US/EU/CAN & WHO) drug product registration (Initial submission, Queries response, Supplement/Variation filling) - Responsible for review of regulatory deficiencies and preparation of justification as per requirement.- Responsible for preparation and review of supplements/ Variation filing (CBE-0, CBE-30 and PAS/Type I and Type II) and its impact on global product management. Evaluation of change controls and providing regulatory strategies for post approval changes.- Preparation of risk assessment reports for Nitrosamines

Vadodara Area, India

. Analytical method development, Validation and Tech Transfer for finished dosage forms (Tablets, Capsule, Injectables, Ophthalmic, Ointments, NDDS) for Assay/Related Substance/Dissolution.. Preparation of regulatory query response and justification report.. Analytical method development and validation protocol/report preparation.. Stability study for FDF.. Literature review for Analytical method development.. HPLC, LC-MS/MS, Disso, Malvern PS, LPC, Anton par etc.. Empower3, Analyst, Phoenix WinNonlin, etc.

Vadodara Area, India

Pune Area, India

IPQA (Testing and release) and QA documentation (BMR, BPR, PVP)

Doctor Of Philosophy (Ph.D.), Pharmaceutical Sciences

Activities and Societies: Biopharmaceutics, Bioanalytical/Analytical R&D, DRA, , Quality Assurance Institute Fellowship

Diploma In Intellectual Property Law, Ipr

Master Of Pharmacy, Quality Assurance Techniques

Quality Assurance Techniques and Pharmaceutical Analysis

Bachelor Of Pharmacy (B.Pharm.)