Open to opportunities

Prasant Singh

@prasantsingh

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Passionate regulatory professional with over 13 years of experience.

India

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What I'm looking for

I am looking for a role that challenges me and allows for professional growth in regulatory affairs.

I am a highly passionate regulatory professional with over 13 years of rich experience in various regulatory domains, including dossier compilation, eCTD publishing, and regulatory compliance across the chemical, pharmaceutical, and IT industries. My journey has equipped me with a deep understanding of regulatory frameworks and compliance requirements, allowing me to navigate complex submission processes effectively.

Throughout my career, I have successfully handled numerous dossier compilations and submissions for global markets, including the US, EU, and Health Canada. I take pride in my ability to manage workflows from start to submission, ensuring that all regulatory submissions meet the highest standards of quality and compliance. My expertise extends to preparing GAP analyses, project trackers, and regulatory intelligence reports, which have proven invaluable in supporting cross-functional teams and internal stakeholders.

I am now seeking a challenging and rewarding opportunity with an organization that recognizes and utilizes my true potential in the field of Regulatory Affairs. I am committed to staying updated on regulatory changes and trends, and I thrive in environments that foster collaboration and innovation.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Compliance Professional

Current

Spectrum Chemical Mfg. Corp.

Mar 2022 - Present (3 years 6 months)

Responsible for handling regulatory compliance work, including preparing GAP analysis, project trackers, and submission planning. Maintained a strong understanding of global chemical regulations and standards such as EU REACH, CLP, and GHS.

Regulatory Compliance REACH Project Tracking Gap Analysis

Team Lead & SME – Regulatory Submission Management - Product

Freyr Solutions

Apr 2020 - Present (5 years 5 months)

Provided Subject Matter Expert support and functional requirements to the technology team for FreyrSubmitPro development, focusing on health authority requirements and regional updates. Supported clients in creating eCTD, NeeS, and regional submissions for various markets using Freyr Submit eCTD Software, managing and resolving validation and submission issues.

NeeS Developer Support UAT Freyr RIMS

Regulatory Scientist - Regulatory Operation

Kinapse India (A Syneos Health Company)

Feb 2017 - Present (8 years 7 months)

Handled dossier compilation and submission, ensuring quality submissions to agencies. Performed document level publishing activities as per established processes and standards, including troubleshooting and quality control checks. Maintained working knowledge of regulatory guidelines and publishing standards, assisting with departmental metrics by tracking project status.

Dossier Quality Control Regulatory Project Tracking Risk Management

Manager – Regulatory Operation

Amneal Pharma Ltd.

Jun 2016 - Present (9 years 3 months)

Interacted with various line units to disseminate regulatory requirements for ANDA applications, CBE 30, and lifecycle maintenance. Prepared and submitted ANDA packages for eSubmission modules using eCTDxPress directly on the FDA portal. Supervised and reviewed ANDA submission packages for readiness and quality, ensuring timely approvals and project compliance.

ANDA Submissions ECTDXPress FDA Lifecycle Management Regulatory Compliance Quality Assurance

Regulatory Scientist – Reg, CMC & Publishing Outsourcing

Kinapse India Scientific Services Pvt. Ltd.

Nov 2011 - Present (13 years 10 months)

Prepared and published eCTD, NeeS, and paper submissions of CMC documents for US and ROW regions using various software like eCTDXPress, ISI Publisher, and Lorenz. Performed report level publishing of clinical reports, appendices compilation, and literature reference compliance checks. Ensured quality dossier submission as per ICH/Regional requirements and managed project and utilization trackers.

ECTD Compliance NeeS Lorenz Project Tracking

Executive - Regulatory Affairs

ELC Group

Jul 2010 - Present (15 years 2 months)

Prepared and submitted dossiers in eCTD/NeeS format for ROW (African, ASEAN, India) and EU countries, including SPCs, PILs, and labelling. Ensured SmPC harmonization, proper bookmarking, hyperlinking, and folder hierarchy in Documentum/File share. Compiled high-quality CMC (Module 3) for European market regulatory filings in compliance with ICH and EMEA guidelines.

ECTD Compliance NeeS Dossier SmPC Harmonization ICH Guidelines

Trainee – Regulatory Affairs

Albert David Ltd.

Apr 2008 - Present (17 years 5 months)

Gained foundational experience in regulatory affairs, assisting with basic documentation and understanding regulatory processes. Supported the team in preparing initial regulatory submissions and maintaining compliance records. Developed an understanding of pharmaceutical industry regulations and data management.

Regulatory Affairs Documentation Compliance Data Management Pharmaceutical