POOJA NILENDRA KHAROSE
Freyr Software Services Pvt. Ltd.
Thane,India
3
Languages
1
Certificate
5
Years of experience
Regulatory Affairs – Submission Publishing professional with experience across EU, US and ROW markets. Experienced in eCTD/CTD submission publishing, pre-publishing, hyperlinking, compilation, validation, dispatch and lifecycle management. Hands-on experience with Veeva Vault (ERV), DocuBridge, Lorenz e-validator, Adobe and MS Office. Experienced in regulatory documentation, submission quality and compliance, stakeholder communication, customer handling and mentoring/team-support activities.
Work History
Senior Associate
1 Year 1 Month- Worked for Takeda Pharmaceuticals as a Regulatory Submission Publisher.
- Ensure regulatory submissions are prepared, formatted and delivered to Health Authorities in compliance with applicable regulations, guidelines and technical standards.
- Perform document formatting and quality control, eCTD management, regulatory compliance, submission delivery and lifecycle management of documents.
- Work with submission publishing tools including DocuBridge and Veeva Vault (ERV).
- Support submission activities with an understanding of FDA, EMA, MHRA and ICH requirements.
Document Management Specialist / Senior Associate
4 Years- Handled ERV (Veeva Vault) projects for EU, US and ROW markets involving eCTD and CTD submissions.
- Performed pre-publishing, publishing, hyperlinking, compilation, validation and dispatch activities.
- Supervised publishing requests from initial processing through dispatch and archival into the repository.
- Handled Variations, MA Transfers, MRP-DCP and Renewals.
- Published, compiled and validated US eCTD dossiers including ANDA, BLA, DMF, IND and NDA applications for CDER and CBER submissions through the ESG portal.
- Processed MAA submissions for EU National, Mutual Recognition Procedure (MRP), Centralized Procedure (CP) and Decentralized Procedure (DCP), including Initial, Renewal, Response and Variation submissions.
- Managed regulatory documentation in line with electronic publishing standards, Health Authority guidelines and SOPs, maintaining a 100% compliance rate.
- Communicated with Regulatory Affairs Managers, Dossier Managers, Marketing Company personnel, data stakeholders and country RA teams to understand requirements and track submission progress and outcomes.
Education
Master of Science - Biotechnology
- First Class
- Four-month project- "Purification of Anti-Thymocyte Globulin" at Bharat Serums & Vaccines Ltd., Airoli (2019–20).
- GPA: 87.95%
Bachelor of Science - Biotechnology
- First Class
- GPA: 75.87%
HSC - Science
GPA: 77.85%
SSC
GPA: 92.36%
Skills
Regulatory Affairs – Submission Publishing
ECTD / CTD / NeeS / Non-eCTD submission formats
EU / US / ROW regulatory markets
Veeva Vault (ERV / RA Submission Publishing)
DocuBridge and Lorenz e-validator
Pre-publishing
publishing
hyperlinking
compilation and validation
Submission dispatch and lifecycle management
Regulatory compliance and document quality control
FDA / EMA / MHRA / ICH guidelines
MS Office – Word
Excel and PowerPoint
Stakeholder management
communication
mentoring and team collaboration
Accomplishments
- Learning Achievement Award – 8 Nov 2021
- Award for Excellence / On the Spot Award – 3 Jan 2022
- Beyond Performance Award – Continuous Feedback Star Certificate – 11 Nov 2022
- Beyond Performance Award – Xcelerate Warrior Certificate – 6 Dec 2022
- Contextual Master Award – 4 May 2023
Certification
- Advance Program in Clinical Research and Management – Clini India, Clinical Research Institute (2020–2021)
- Metamorph – Certificate in Life Science Domain
- Elevate Wings 1 – Life Science Curriculum
- Elevate Wings 1 – Regulatory Affairs (Modules 1 & 2)
- Competencies developed in Team Skill, Taking Ownership, Problem Solving and Interpersonal Skills.
LANGUAGES
English – Advanced (C1)
Hindi – Advanced (C1)
Marathi – Bilingual / Proficient (C2)
Timeline
Senior Associate
Freyr Software Services Pvt. Ltd.
09.2025 - CurrentRead More
Document Management Specialist / Senior Associate
Tata Consultancy Services (TCS)
08.2021 - 08.2025Read More
Pillai College, Mumbai University, Panvel
Bachelor of Science from Biotechnology
Read More
HSC from Science
Read More
SSC
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Pillai College, Mumbai University, Panvel
Master of Science from Biotechnology
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Personal Information
Title: Regulatory Affairs – Submission Publishing | Senior Associate
Section name
Pooja Kharose | Regulatory Affairs – Submission Publishing
Personal Information
Title: Regulatory Affairs – Submission Publishing | Senior Associate