Lakshmi Narasimha Naveen Yamana
Grafton,MA
Summary
With a robust background at Anavex Life Sciences Corp, I spearheaded the establishment of the Regulatory Operations Department, enhancing efficiency and profit margins significantly. Expert in IQVIA RIMSMART and adept at leading cross-functional teams, my strategic initiatives and vendor negotiations have consistently driven organizational success, demonstrating unparalleled leadership and technical proficiency.
Overview
24
24
years of professional experience
Work History
Sr. Director, Regulatory Operations
Anavex Life Sciences Corp
New York, NY
06.2024 - Current
- Set up the Regulatory Operations Department.
- Compile the work instructions for the processes within Regulatory Operations.
- Implemented a Document Management System to act as a repository for Clinical, Data Management, CMC, PV, and Regulatory.
- Migration of data from SharePoint to the cloud-based document management system.
- Implemented in-house regulatory publishing tool, regulatory viewer, and regulatory validator.
- Implemented and trained all cross-functional groups in regulatory templates.
- Implemented the Electronics Submission Gateway for the FDA and EMA.
- Manage the internal team and external vendors.
- Directed operations to improve efficiency and increase profit margins.
- Monitored industry trends and made recommendations on how they could be leveraged by the organization.
- Negotiated high-value contracts with vendors and partners to optimize resource allocation.
- Established key performance indicators to track progress towards goals.
- Planned and delivered training sessions to improve employee effectiveness and address areas of weakness.
- Managed multiple projects simultaneously while ensuring deadlines were met.
- Collaborated with executive leadership team to develop long-term objectives that would drive success.
- Oversaw budgeting processes and ensured fiscal responsibility was maintained throughout the year.
- Implemented new technologies to streamline processes and enhance productivity.
- Facilitated meetings between internal teams to ensure alignment on initiatives.
Director, Regulatory Operations
Acer Therapeutics, Inc
06.2020 - Current
- Implementation of ARIM Regulatory Publishing System
- Implementation of GlobalSubmit Regulatory Templates
- Provide Training to different stake holders on the Templates
- Develop Work Instructions for the Use of Templates
- Develop and Update SOP's and Work Instructions for departmental process flows
- Developed Inhouse Submission Calendar in Microsoft Teams (SharePoint)
- Manage day to day submission activities per the submission calendar
- Develop plan for Submission Archive and Correspondence
- Manage Publishing vendors
- Convert Paper INDs to eCTD
Senior Manager, Regulatory Operations, Global Regulatory Affairs
Sunovion Pharmaceuticals, Inc
04.2018 - 06.2020
- Implementation of Regulatory Information Management System (RIM)
- Provide Training to different stake holders on the new RIM system
- Develop Work Instructions for the Use of RIM system
- Develop and Update SOP's and Work Instructions
- Manage day to day submission activities per the submission calendar
- Develop plan for Submission Archive and Correspondence within RIM system
- Manage Publishing vendors
- Convert Paper DMF's and VMF to eCTD
- Implement electronic OPDP submissions
Manager, Regulatory Operations, Global Regulatory Affairs
Sunovion Pharmaceuticals, Inc
04.2015 - 04.2018
- Mentor colleagues and new hires
- Manage the training and onboarding of the new hires within the department
- Manage the business process development activities for the department
- Manage day to day submission activities per the submission calendar
- Test, Validate and help train on the new publishing system
- Manage Publishing vendors
- Help with Template training to the extended team
- Perform speaker audits as a volunteer for the compliance
- Perform trouble shooting of the publishing software issue to help with seamless publishing activities
- On core team working on implementing the new module 1 changes and moving to electronic OPDP submissions
Regulatory Submissions Specialist
Sunovion Pharmaceuticals, Inc
06.2011 - 03.2015
- Managed the successful submission of 2 IND's by acting as the Regulatory Operations Lead
- Experience in handling OPDP Spoke on eCTD Validation Criteria/Changes in April, 2012 at a Regulatory Writers conference in Baltimore
- Panel Member for discussion on best practices on Regulatory Writing, Publishing, Review and Validation
- Experience in handling Software Vendor Evaluation
- Manage the publishing aspects of multiple NDA's and IND's
- Worked on a total life cycle management of Drug application process
- Setup standards for publishing, qc and review
- Setup eCTD submission validation (Previously DDMAC) submissions for 9 marketed products
- Working on transition of paper OPDP submissions to electronic
- Managing a team for an IND submission
- Played a major role in a successful submission of 2 NDA's and 3 IND's
- Publishing of Regulatory Documents for multiple compliance submissions
- Working closely with multiple vendors to evaluate the software for the company
- Played an active role in the validation of eCTD publishing software
- Working on harmonization process between two site in terms of process and publishing standards
- Knowledgeable in submission of SPL and Establishment Registration processes
- Responsible for multiple NDA's and IND's compliance submissions
- Setup standards and submission process for PDMAs and Field Alerts based on Six Sigma standards
- Working towards initiating Six Sigma standards in publishing process
- Provide support for other teams in terms of publishing, qc and validation of eCTD submissions, SPL's and Establishment Registrations
- Managed Drug Master File submissions and submission process
Regulatory Analyst/ Specialist
Pyramid Technology Solutions, Inc.
Marlborough, USA
10.2007 - 06.2011
- Company Overview: Client: Sunovion Pharmaceuticals, Marlborough, MA
- Publishing reports and Submission using Octagons Viewpoint publishing tool
- Strong exposure and working Knowledge in using ISI Publisher and ISI Toolbox
- Published Submissions using Viewpoint Publishing tool to different agencies such as FDA (US) and EMEA (EU)
- Active Involvement in the submission of an MAA, an IND and also NDA
- Involved in maintenance submissions like CBE-0, CBE-30, Labeling, SPL/FPL etc
- Involved in processing complex documents for Regulatory Submissions and archival purposes (Electronic and Paper)
- Involved in the total drug application life cycle for MAA, IND and NDA
- Involved in the process of migrating the existing publishing system to latest versions and software upgrades
- Extensive Knowledge in using Adobe tools
- (Adobe Reader, Distiller, etc)
- Involved in the validation and review of eCTD submissions using Octagon and GlobalSubmit Validator, Octagon and GlobalSubmit Viewer
- Experienced in publishing both Electronic and Paper submissions
- Published (Bookmark and Hyperlink) Clinical Protocols and Reports, work with others to QC Bookmarks and Hyperlinks prior to finalization
- Debugging the errors in the process of publishing volumes
- Responsible for checking various logs and ensure documents are produced in accordance with department procedures and in accordance with companies' SOPs
- Worked with project teams to maximize the use and value of document templates and developed document formatting standards
- Worked with regulatory associates and clinical research personnel to assist in the development, distribution, filing and storage of regulatory documents, investigational new drug applications, and new drug applications
- Involved in developing a department wide instruction manual on all the tools and software's that Regulatory Operations uses
- Client: Sunovion Pharmaceuticals, Marlborough, MA
Software Engineer
Eigen Solutions Inc
04.2007 - 09.2007
- Provided Software Design after gathering the requirements
- Researching new software designs using emerging technologies
- Responsible for tool customization as per client requirements
SAS Programmer & Data Miner
Retain Team, Verizon Wireless
Dallas, USA
09.2006 - 02.2007
- Performed Data Mining using SAS/ENTERPRISE MINER for fraud detection and credit card transaction discrepancies in the traders and customer's transaction data
- Involved in Data extraction from the TeraData warehouse and performing data validation
- Used Proc Report for report generation as per client requirement
- Extensively used SAS/GRAPH for generating graphical reports as per the client guidelines and the also considering the required attributes
- Used PROC SUMMARY, PROC MEANS, PROC TABULATE, and PROC UNIVARIATE report generation depending upon the client requirement
- Generating ad-hoc reports on the customer status
- Involved in generating weekly and monthly consumer status reports
Graduate Research and Teaching Assistant
Indiana State University
Terre Haute, USA
06.2004 - 08.2006
- Involved in developing lab programs for Graduate and Undergraduate students
- Experience in Handling Mitsubishi, Fanuc and Adept Robots
- Taught Undergraduate Students on Robotic and PLC programming
- Designed Robotic Tooling to emulate real life robotic applications in different fields like manufacturing, machine assembly, palletizing etc
- Using Pro E/Wildfire
- Rapid prototyping of the designed tools on the FDM 3000 rapid prototyping machine
- Performed interface between the robotic and PLC systems
- Developing programs for the PLC programming lab on Allen Bradley make of PLC's to simulate real time work flow
- Managed a group of 20 students to train them in PLC programming for the Graduate class of ECT 663 and AC circuits for ECT 220 undergraduate class
- Managed a group of 22 students to train them in programming Mitsubishi, Adept and Fanuc robots for the graduate class of ECT 661 & ECT 280 and DC circuits for ECT 160 undergraduate class
Student Computing Centre
Indiana State University
Terre Haute, USA
01.2004 - 06.2004
- Involved in generating monthly student lab usage reports in SAS using PROC Report and PROC Summary
- Handled Students queries on Operating system and Microsoft Office tools
- Involved in developing online forms for taking regular surveys from the students using the computer lab to further enhance the facilities in the lab
Technical Support Engineer
SONY, Sutherland Technologies
, India
01.2003 - 01.2004
- Assisted Sony customers worldwide with their technical problems relating to their digital and computer products
- Worked as the quality assessment supervisor for a team of 12
- I personally assessed the trouble shooting ability of the technical support agent and checked for customer satisfaction thereby determining the quality score the agent which is used in accessing the performance based incentives for the agents
Engineering Trainee
Jegurupadu Thermal Power Station
, India
01.2001 - 06.2002
- As a control engineer trainee, I have to keep track of the excitation system of the power station and its parameters from the main control room of the thermal power station
- Had to initiates safety measures if there were any anomalies such as short circuits and power factor deficiencies
- Designed the automatic voltage regulator for the power station
Education
International MBA - Health Care Management
Southern New Hampshire University
NH01.2025
MS - Regulatory and Clinical Research Management
Regis College
MAMS. Certificate - Project Management
Worcester Polytechnic
MAMS Certificate - Six Sigma
Villanova University
Villanova, PAMS - Electronics and Computer Technology
Indiana State University
Terre Haute, INBS - Electrical and Electronics Engineering
Bharathiar University
Coimbatore, TN, IndiaSkills
- IQVIA RIMSMART Publishing Tool
- Octagon Viewpoint
- Global Submit Publishing Suite
- ISI's eCTDXPress
- ISI Publisher
- IQVIA IRPT PDF Tools
- ISI/TRS Toolbox
- Adobe Tools
- Starting Point Templates
- Certera/Synchrogenix Templates
- Egnyte
- Documentum 5x
- First Docs
- GDMS
- Microsoft Teams
- Sharepoint
- Veeva RIM
- Microsoft Teams
- Microsoft Office
- Microsoft Project
- SmartSheet
- SAS
- Allen Bradley PLC programming-RS Logix 500
- Control Logix 5000
- Pro E/Wildfire
- Rockwell Automation RS View programming
- Supervisory Control and Data Acquisition (SCADA) programming
- Programming of ADEPT
- Mitsubishi robots
- Fanuc robots
- AIM
- V
- Roboware
- Melfa Wine
Timeline
Sr. Director, Regulatory Operations
Anavex Life Sciences Corp
06.2024 - Current
Director, Regulatory Operations
Acer Therapeutics, Inc
06.2020 - Current
Senior Manager, Regulatory Operations, Global Regulatory Affairs
Sunovion Pharmaceuticals, Inc
04.2018 - 06.2020
Manager, Regulatory Operations, Global Regulatory Affairs
Sunovion Pharmaceuticals, Inc
04.2015 - 04.2018
Regulatory Submissions Specialist
Sunovion Pharmaceuticals, Inc
06.2011 - 03.2015
Regulatory Analyst/ Specialist
Pyramid Technology Solutions, Inc.
10.2007 - 06.2011
Software Engineer
Eigen Solutions Inc
04.2007 - 09.2007
SAS Programmer & Data Miner
Retain Team, Verizon Wireless
09.2006 - 02.2007
Graduate Research and Teaching Assistant
Indiana State University
06.2004 - 08.2006
Student Computing Centre
Indiana State University
01.2004 - 06.2004
Technical Support Engineer
SONY, Sutherland Technologies
01.2003 - 01.2004
Engineering Trainee
Jegurupadu Thermal Power Station
01.2001 - 06.2002
International MBA - Health Care Management
Southern New Hampshire University
MS - Regulatory and Clinical Research Management
Regis College
MS. Certificate - Project Management
Worcester Polytechnic
MS Certificate - Six Sigma
Villanova University
MS - Electronics and Computer Technology
Indiana State University
BS - Electrical and Electronics Engineering
Bharathiar University
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