Munendra Kumar Email & Phone Number

Mumbai, Maharashtra, In

Regulatory strategy for Global dossier (CMC)submissions across US/EU/ROW regions. ANDAs/NDA submissions to USFDA.Regulatory Submissions, CMC (CTD/ Regional specific) to EU regions and other Regions of world (ROW).Ensuring DCP/MRP/ National application approval as per agreed business timelines.Global Labelling Management for Generic/ Innovator Product portfolios.CCDS creation and maintenance activities via electronic document management systems.Artwork management via electronic tools and systems.Owner of eCTD system and ensuring all Global submissions ( ANDA, NDA, MAs) are submitted within agreed timeline. RIMS maintenance for Global product portfolio and xEVMPD submissions for EU region.

Fort Washington, Pennsylvania, Us

1. Created Regulatory team for EMEA, US and APAC region for delivering projects for Top 3 Pharmaceutical and consumer health organization, OTC product portfolio.2. Managing technical team (150 RESOURCES) of qualified people for on-time delivery of Regulatory Projects across EU, US and APAC region for Top 3 Pharmaceutical and consumer health organization.3. Client management via regulatory intelligence, POC and Oral communication (TC/VC).4. Technical support to regulatory associates on regulatory submissions and coordination of eCTD compilation of dossiers of leading OTC brands in US, EU and ROW.5. Technical support on CMC, SmPC, Labelling, Post approval changes for OTC products6. Supporting business development team with regulatory input on various aspects as per customized client need.7. Improve work processes at define levels of the company for effective resource management and Budget Planning.8. Responsible for hiring, on-boarding and professional development of regulatory team members.9. Subject matter expert for Consumer Healthcare Products registrations globally for various dosage form, Solid oral, Semi-solid, liquid oral, Spray and Parenteral).

Stockholm, Se

1.Managing technical team of qualified people (employees & consultants) and coordinating activities (DCP, MRP, Repeat use MRP, Parallel DCP, CMC Variation, Clinical and Labelling Variation and EU Renewal) for maximizing the value of company portfolio.2. Improve work processes at define levels of the company for effective resource management and Budget Planning.3. Member of the Management Team, developing the structure and strategy of the company and its affiliates.4. Regulatory input for development projects so as to increase the product portfolio.5. Directly interacting with QP for ensuring compliance and provided necessary regulatory input for batch release in EU.6. Performing Dossier Audit for In-Licensing and increasing product portfolio.7. Extending European approval to ROW market by means of Fast tracking approval procedures.8. Supporting QPPV in PSMF and RMP preparation.9. Submitting PSMF for Bluefish with EU Health Authorities and updating Article 57 database with EMEA.10. Representing Regulatory affairs in PV audit with MPA.

Basel, Baselstadt, Ch

Development products (NCEs), Marketed brands (NDA/MAA), Generics (ANDA/EU Submission via MRP, CP and DCP) and Technical Operations/Technical Research and Development/ Global or Country specific regulatory requirements/guidance.NDA Submission, CBE 30, PAS Submission, Annual Report for NDAs.CP/MRP submission for MAA in EU, Renewal and Variation Submissions.Project Management and Global Regulatory Strategies (US, EU and ROW).Global Liaison Manager to manage Change control system for EU, US and ROW.Developing various Matrix system as part of LEAN initiative.

Technical CMC documentation in CTD/NTA formats for Generic drug product registration in the US and European Union.Drug product registration in the European Union via National, MRP and DCP procedures.Compilation and submission of complete dossier (Module 1, 2, 3 and 5) for US ANDA.Complete compilation, validation and publishing of ANDA in eCTD format.Regulatory and technical evaluation of analytical, quality and Bio Equivalence documents for EU and US submission.OTC dossier for US, CBE 30, PAS and Annual Report submission.Technical evaluation of quality (Analytical Validation, process validation, BMR, BPR, PDR, Stability etc) and clinical documents (BE protocol and report)