Pranita Hadkar

Operations Associate

Mumbai, Maharashtra, India8 yrs 3 mos experience

Highly Stable

Key Highlights

Expert in regulatory operations and eCTD submissions.
Green Belt in Lean Six Sigma enhancing operational efficiency.
Proficient in Veeva Vault and IDMP data management.

Stackforce AI infers this person is a Regulatory Operations Specialist in the Pharmaceutical industry with expertise in compliance and data management.

Contact

Skills

Core Skills

Regulatory AffairsPublishingRegulatory Information ManagementIdmp

Other Skills

eCTDDocument ManagementBiosimilars SubmissionVeeva VaultCARAData ValidationData EnrichmentLiquent InsightTimelinesCommunicationQuality ControlGreen Belt CertifiedAnalytical SkillsRegulatory SubmissionsGood Clinical Practice (GCP)

About

With an MBA in Operations Management from NMIMS, I am the Regulatory Operations Specialist at Abbott, ensuring seamless lifecycle management and publishing for the APAC region, including biosimilars submissions. My expertise in eCTD and regulatory databases supports our team's commitment to excellence and compliance. A Green Belt in Lean Six Sigma, I bolster the operational efficiency of our regulatory processes. My tenure at Genpact honed my skills in Veeva Vault and CARA, contributing to meticulous IDMP data maintenance and regulatory submissions, which are vital in the fast-paced pharmaceutical industry.

Experience

8 yrs 3 mos

Total Experience

2 yrs 8 mos

Average Tenure

2 mos

Current Experience

Amgen india

Senior Associate

Apr 2026 – Present · 2 mos · Hyderabad · On-site

Abbott

Regulatory Operations Specialist

Apr 2023 – Apr 2026 · 3 yrs · Mumbai, Maharashtra, India · Hybrid

Responsible for maintaining Registered Position of approved drug in company's internal database
Responsible for eCTD, export services publishing
Lifecycle Maintenance and Publishing of APAC, CIS, METAP regional documents.
eCTD dossier structure preparation and document management in DMS
Directing in development of product registration submission, progress reports, supplements, amendments or periodic experience reports
Serving as Regulatory liaison throughout product lifecycle
Biosimilars Submission for APAC region

eCTDRegulatory AffairsPublishingDocument ManagementBiosimilars Submission

Genpact

Lead Associate

May 2022 – Apr 2023 · 11 mos · Mumbai, Maharashtra, India · Remote

Regulatory Information Management, Veeva Vault, CARA 5.7, DocuBridge.
Veeva Vault data Validation, Data Enrichment Vault Consolodation. Metadata Enrichment of EU Registrations in Veeva Vault
IDMP data maintenance, DADI fields mapping using FHIR sheet, SPOR and Referential Information tracking for IDMP initiation activity.
Knowlege of EU-CTD structure and ICH GCP

Veeva VaultCARAIDMPData ValidationData EnrichmentRegulatory Information Management

Tata consultancy services

2 roles

Regulatory Affairs Associate

Jul 2018 – May 2022 · 3 yrs 10 mos

Regulatory Information Management in tools like Liquent Insight, Veeva Vault, Integrated Module Management System, EV Web
Maintenance of Module 3 CMC data in approved database
Creation of Variation Events, Assemblies and Sequences and LCM in Liquent Insight
IDMP data maintenance
Veeva Vault metadata enrichment for Registrations and Medical Devices

Regulatory Information ManagementLiquent InsightVeeva VaultIDMP