Varuni Kollu
Hyderabad
Summary
Global regulatory affairs and CMC project management expert with over 13 years of experience in leading drug registration programs across multiple markets, including US FDA, EU, Health Canada, Rest of the World markets. Proficient in developing structured, milestone-driven project plans that integrate R&D, quality, manufacturing, supply chain, and commercial stakeholders into a cohesive regulatory strategy. Experienced in lifecycle management of ANDA, MAA, and NDS submissions, health authority query resolution. Bringing disciplined, right-first-time program governance, risk mitigation and cross-functional delivery to fast-paced, matrixed pharmaceutical environments with a natural bridge between R&D science and project execution.
Overview
13
13
years of professional experience
Work History
Assistant Manager, Regulatory Affairs
Amarant Life Sciences
12.2025 - Current
- FTE (Full-Time Equivalent) engagement supporting Centrient's EU regulatory portfolio
- Life-cycle project management of marketing authorizations across the EU and South Africa, coordinating regulatory, technical and commercial stakeholders to keep submission and renewal milestones on track.
- Lead technology-transfer regulatory workstreams driving data-compliance reviews and translating transfer plans into actionable regulatory strategy documents for cross-site project teams.
- Serve as regulatory lead for the Veeva Vault RIM rollout, designing training content and supporting system migration governance.
- Chair gap-assessment reviews of CMC documentation, converting findings into structured remediation plans with clear ownership and timelines.
- Direct checklist development and review of risk assessments for drug substance and finished product, partnering with R&D and Analytical teams on in-silico evaluation strategy.
- Redesign submission-preparation workflows to compress review cycles and strengthen first-pass approval quality.
- Oversee review of third-party/CRO-generated technical documents, study protocols and Environmental Risk Assessment reports on behalf of the sponsor, ensuring vendor deliverables meet regulatory and project timelines.
- Maintain and update Master Data Sheets and RegPacks as the single source of truth for cross-functional submission planning.
Deputy Manager, Regulatory Affairs
Gland Pharma Limited
Hyderabad
03.2022 - 08.2025
- Managed end-to-end CMC dossier projects initial applications, variations and renewals coordinating timelines across QA, Manufacturing and R&D to deliver right-first-time submissions.
- Ran gap assessments and built mitigation strategies for risk-prone filings, prioritizing project workstreams by regulatory impact and program risk.
- Acted as the regulatory bridge to R&D and Manufacturing, sourcing and verifying BMRs, process validation data and site compliance documentation to support submission readiness.
- Led regulatory impact assessments for process and site changes, advising cross-functional project teams on compliant, schedule-efficient change pathways.
- Tracked evolving global guidelines (ICH, USFDA, EMA) and translated regulatory intelligence into internal process updates and submission strategy adjustments.
- Supported FDA audit readiness through documentation packages and narrative justifications, partnering closely with QA and site project teams.
- Maintained a centralized submission tracker, giving leadership real-time visibility into project status across markets.
Research Associate, Formulation R&D
Hetero Healthcare Limited
Hyderabad
07.2017 - 03.2022
- Bridged R&D and Regulatory Affairs by converting formulation development data directly into dossier content for US and semi-regulated markets.
- Reviewed validation protocols, product development reports and Analytical Method Validations to confirm Module 3 readiness ahead of submission.
- Coordinated query-response preparation across product, process and analytical functions, keeping response timelines aligned to agency deadlines.
- Partnered with site teams to ensure Module 3 documentation matched manufacturing-site operations, reducing rework during dossier compilation.
Formulation Scientist, FRD / Regulatory Affairs
Simson Life Sciences
Hyderabad
03.2015 - 03.2017
- Established work instructions and project workflow standards for formulation development, improving consistency across development programs.
- Selected APIs, excipients and container-closure vendors, coordinating supplier timelines within overall project plans.
- Led development and execution of trials for injectable and ophthalmic formulations, applying QbD principles to build submission-ready, stable formulations.
- Managed end-to-end project flow from sourcing through client submission, coordinating with QA and plant teams at each milestone.
- Authored SOPs, process reports and manufacturing batch documentation supporting product development projects.
Research Associate, FRD
TherDose Pharma
Hyderabad
12.2013 - 03.2015
- Conducted product development studies and compiled CTD/ACTD applications per country-specific regulatory requirements.
- Authored CMC narrative sections in line with CTD quality requirements, and reviewed raw-material, in-process and packaging specifications.
- Supported tender and licensing documentation, and reviewed plant records (specifications, batch records, stability data) for compliance.
- Assisted line management in preparing responses to client and regulatory-authority dossier queries, and in preparing labels and pack inserts.
Education
Master of Pharmacy (M.Pharm) -
Kakatiya University
Janagaon, Telangana01-2013
Bachelor of Pharmacy (B.Pharm) -
Jawaharlal Nehru Technological University
Hyderabad, Telangana01-2011
Intermediate - Biology, Physics & Chemistry (BiPC)
Kodad, Telangana01-2007
Skills
- Regulatory strategy
- Lifecycle management
- Submission milestone planning
- Gap analysis
- Mitigation planning
- Remediation planning
- Risk register development
- Regulatory Technology Integration
- Quality & Compliance
- GxP documentation governance
- Veeva Vault RIM
- CRO Compliance Management
- CDMO documentation oversight
- Third-party documentation oversight
- Process re-engineering
- Continuous improvement
- Cross-functional leadership
- Milestone management
- Project Accountability
- SOP authorship
- Work-instruction authorship
Accomplishments
- Awarded 'Best Outgoing Student' — M.Pharm, Kakatiya University
- Recognition award, Simson Life Sciences, for technical excellence
Certifications And Systems
- Lean Six Sigma Green Belt
- Veeva Vault RIM submission management & migration
- Regulatory standards: eCTD, ICH, GxP, USFDA/EMA, HC and global compliance frameworks
Timeline
Assistant Manager, Regulatory Affairs
Amarant Life Sciences
12.2025 - Current
Deputy Manager, Regulatory Affairs
Gland Pharma Limited
03.2022 - 08.2025
Research Associate, Formulation R&D
Hetero Healthcare Limited
07.2017 - 03.2022
Formulation Scientist, FRD / Regulatory Affairs
Simson Life Sciences
03.2015 - 03.2017
Research Associate, FRD
TherDose Pharma
12.2013 - 03.2015
Master of Pharmacy (M.Pharm) -
Kakatiya University
Bachelor of Pharmacy (B.Pharm) -
Jawaharlal Nehru Technological University