Vamshi Krishna Baline
Senior Manager - Regulatory Affairs
Mumbai,MH
Summary
Results-driven Regulatory Affairs professional with 14+ years of experience spanning Regulatory CMC, Regulatory Publishing, People Management, and Project Management, bringing strategic leadership and operational excellence to drive organizational success. Skilled in project management, team collaboration, and process optimization with keen focus on achieving results. Adept at navigating complex challenges, fostering culture of accountability, and adapting to evolving business needs. Known for strong decision-making, effective communication, and building high-performing teams, experience spanning Regulatory
CMC, Regulatory Publishing, People Management, and Project Management. Proven expertise in developing and managing CMC strategies, preparing and reviewing quality/CMC modules (Module 2 & 3 of CTD/eCTD), and ensuring compliance with global regulatory requirements (US, EU, ASEAN, ROW).
Overview
16
16
years of professional experience
Work History
Senior Manager – Regulatory Affairs
TATA CONSULTANCY SERVICES
08.2016 - Current
- Developed and implemented a comprehensive delivery plan that enabled the successful completion of projects within budget and ahead of schedule.
- Monitored project progress and identified potential risks, mitigating issues that could cause project delays and cost overruns.
- Created automated reporting systems that tracked project milestones and enabled data-driven reports.
- Prepared and presented financial reports to senior management and external stakeholders.
- Led regulatory submissions and compliance initiatives, ensuring adherence to evolving industry standards and enhancing approval timelines.
- Directed Regulatory CMC submissions including Module 2 & 3 for INDs, NDAs, ANDAs, MAAs, variations, supplements, and amendments across US, EU, and ROW markets.
- Oversaw regulatory publishing activities (eCTD, NeeS, paper) ensuring dossier quality, compliance with ICH/regional guidelines, and timely submissions.
- Provided CMC and publishing strategy for new product development and lifecycle maintenance.
- Developed and implemented strategic regulatory frameworks, driving alignment with global regulatory requirements and improving operational efficiency.
- Managed a 30+ member team; provided coaching, mentoring, and performance management to achieve business goals.
- Implemented automated project tracking/reporting systems, improving efficiency and visibility.
Lead – Regulatory Affairs
iMEDGlobal Solutions
08.2014 - 08.2016
- Managed preparation and submission of CMC sections for global filings (US, EU, ASEAN).
- Coordinated with publishing teams to ensure error-free and timely electronic submissions.
- Reviewed technical CMC documentation (manufacturing process, controls, analytical methods).
- Partnered with business teams to support market clearance by timely dossier submissions.
- Provided regulatory guidance and mentorship to new team members.
- Collaborated with external stakeholders to align regulatory strategies with business objectives, driving successful product launches and market access.
Team Lead – Regulatory Affairs
Accenture
08.2011 - 08.2014
- Led regulatory publishing team for global submissions; created dossier structures, assigned documents, and performed document- and submission-level QC.
- Point of contact for troubleshooting publishing issues (validation errors, PDF compliance, hyperlinks/bookmarks).
- Delivered multiple submissions simultaneously while ensuring adherence to client timelines.
- Supervised junior associates, providing training and guidance on regulatory publishing best practices.
- Developed and implemented streamlined processes for regulatory submissions, significantly reducing approval timelines and improving resource allocation.
Executive – Regulatory Affairs
Granules India
09.2009 - 09.2010
- Compiled and submitted CMC sections of ANDAs and DMFs in CTD format to USFDA.
- Supported regulatory publishing of dossiers, ensuring format compliance and readiness for submission.
- Coordinated with R&D and QA teams to align submission strategy with product development.
- Conducted internal audits and dossier reviews to ensure quality and accuracy.
Education
Master of Pharmacy - Pharmaceutics
Vels College of Pharmacy
Chennai03-2009
Skills
Leadership capabilities
Accomplishments
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Achieved work tracking reports and dashboards by introducing ADD platform for Document level and Submission level tasks.
Hobbies - Cricket
As a all round player by nature, won several trophies during schooling and college duration and also won at corporate initiative engagements.
Timeline
Senior Manager – Regulatory Affairs
TATA CONSULTANCY SERVICES
08.2016 - Current
Lead – Regulatory Affairs
iMEDGlobal Solutions
08.2014 - 08.2016
Team Lead – Regulatory Affairs
Accenture
08.2011 - 08.2014
Executive – Regulatory Affairs
Granules India
09.2009 - 09.2010
Master of Pharmacy - Pharmaceutics
Vels College of Pharmacy