Lokesh MS
Senior Manager - Commercial Operations
Bangalore
Summary
With a proven track record in overseeing commercial and regulatory operations at Sayre Therapeutics Private Limited, I successfully managed multi-domain projects, driving significant improvements in operational and project management efficiency.
Overview
10
10
years of professional experience
Work History
Senior Manager: Commercial Operations
Sayre Therapeutics Private Limited
05.2022 - Current
- As part of commercial management, I oversaw projects across various domains to ensure seamless operations. These domains include diagnostic business portfolios, institutional business, regulatory operations and strategy, international logistics, inventory management, and CRM management.
- Served as the project manager for the diagnostic portfolio, managing a business worth five crores. This role involved coordinating with internal and external stakeholders to ensure smooth business operations.
- Inventory Management and Production Planning: Regularly monitored inventory at primary and secondary locations to ensure a smooth product supply, prevent stock-out situations, and reduce the inventory holding days.
- Established the end-to-end supply process for importing novel products under the special access program, managing everything from licensing to coordinating with multiple stakeholders to ensure safe delivery of products to hospitals from manufacturing sites in the US and EU.
- Participated in several negotiation meetings with hospitals across India as part of the institutional business.
- Managed the CRM and digital marketing tools to monitor activities and sales performance of a field team of 20+ members, including progress tracking and call analysis.
- Continued supporting the business development team by providing regulatory strategies for drugs, devices, and radiopharmaceutical products.
Manager Regulatory & Clinical Affairs
Sayre Therapeutics Private Limited
07.2021 - 04.2022
- Served as a core team member in the One-Year Stanford Seed Program, contributing to the development of the company's growth strategy.
- Acted as Project Manager for a Phase IV Clinical Trial in India, coordinating with multiple stakeholders, including CROs.
- Played an active role in marketing efforts and contributed to the establishment of a second-opinion platform for cancer patients. Also, actively participated in digital marketing initiatives during the implementation phase.
- Supported the Institutional Business team with dossier preparation and bid submissions.
Assistant Manager Regulatory & Clinical Affairs
Sayre Therapeutics Private Limited
07.2018 - 06.2021
- Developed and executed regulatory strategy for importing and marketing new drugs in India.
- Managed end-to-end regulatory activities to secure Marketing Authorization Approval, Registration Certificate, and Import License Application for new drug registration in India.
- Served as the regulatory point of contact for query response submissions to CDSCO, coordinating with CDTL and IPC.
- Prepared dossiers and presentations for SEC meetings, participating in three SEC meetings with successful outcomes (i.e., recommendations for approval).
- Contributed to the pre-launch planning team for new drugs in India.
Associate Manager: QA and RA
PharmaLeaf India Private Limited
04.2017 - 07.2018
- Managed regulatory submissions of new drugs, generics, and medical devices to CDSCO, including successful domestic manufacturing approval for a medical device.
- Handled techno-commercial activities such as project scoping, RFP preparation, proposal review, cost analysis, scope creep identification, and project lifecycle management.
- Led a team of 3 members, overseeing client communication, publishing, agency liaison for project completion, and label due diligence activities, ensuring compliance with Indian regulations.
- Acted as Project Manager for Analytical Method Development, validation, and stability studies of herbal products, coordinating multiple stakeholders.
- Part of the eCTD implementation team, trained in and executed eCTD publishing using PharmaReady eCTD Software, and established a robust system for eCTD publishing and marketing.
- Published ANDA and CEP applications for USFDA and EMA, successfully compiling and submitting the ANDA application before the end of US FY 2017.
- Led the manufacturing facility team to complete the state licensing authority inspections.
Junior Associate Manager: QA and RA
PharmaLeaf India Private Limited
04.2016 - 04.2017
- Led a team to maintain QMS and MIS for effective project tracking and corrective actions.
- Coordinated internally to improve MIS for project metrics and corrective actions.
- Compiled and published RC and IL applications for generics and medical devices registration in India.
- Led a successful vendor qualification audit by a reputed MNC.
- Part of the team member in setting up the manufacturing facility for medical devices in Bangalore.
- Established a QMS for a chain of clinics in Bangalore.
Trainee: QA and RA
PharmaLeaf India Private Limited
04.2015 - 04.2016
- Supported QA team in restructuring QMS and managing SOP revisions and implementations.
- Provided QA oversight for a new medical device manufacturing facility.
- Secured import license and completed NIB testing for Non-Notified IVDs (Glucometer) in India.
- Prepared and published 10 dossiers to obtain Import NoC and Export NoC from ICMR with zero queries.
Education
M Pharm - Quality Assurance
JSS College of Pharmacy
Mysore, India 04.2001 -
B Pharm - B Pharm
JSS College Of Pharmacy
Mysore, India 04.2001 -
Skills
MS Office products (such as Word, PowerPoint, Excel)
undefinedAccomplishments
- Student Coordinator for NSS in JSS College of Pharmacy
- Awarded as The Best NSS Volunteer at the University level
- Have been Vice-President for the year 2013-14 and Cultural Secretary for the year 2012-13
Affiliations
- Karnataka State Pharmacy Council
Languages
English
Bilingual or Proficient (C2)
Hindi
Upper intermediate (B2)
Kannada
Advanced (C1)
Timeline
Senior Manager: Commercial Operations
Sayre Therapeutics Private Limited
05.2022 - Current
Manager Regulatory & Clinical Affairs
Sayre Therapeutics Private Limited
07.2021 - 04.2022
Assistant Manager Regulatory & Clinical Affairs
Sayre Therapeutics Private Limited
07.2018 - 06.2021
Associate Manager: QA and RA
PharmaLeaf India Private Limited
04.2017 - 07.2018
Junior Associate Manager: QA and RA
PharmaLeaf India Private Limited
04.2016 - 04.2017
Trainee: QA and RA
PharmaLeaf India Private Limited
04.2015 - 04.2016
M Pharm - Quality Assurance
JSS College of Pharmacy
04.2001 -
B Pharm - B Pharm
JSS College Of Pharmacy
04.2001 -
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