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Lini Subin

@linisubin

Senior Regulatory Affairs leader specializing in global pharmaceutical CMC dossier development and lifecycle maintenance for EU and beyond.

India

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What I'm looking for

I’m seeking a role where I can lead global regulatory/CMC submissions and lifecycle maintenance—driving dossier quality, strategy, and regulator interactions across EU and international markets while partnering with cross-functional teams.

I’m a dynamic, result-driven Regulatory Affairs leader with over 2 1 years of continued enhancement and expertise in Global Pharmaceutical Regulatory Affairs (Formulation). I’ve worked as a Regulatory Strategist/Subject Matter Expert (CMC & RA) supporting internationally recognized pharmaceutical companies with dossier development and regulatory submissions for successful marketing authorization.

My depth is strongest in EU Registration procedures (DC/MR, CP and National Procedures), with experience in more than 500 EU procedures. I also specialize in life-cycle maintenance (variation filings) at an operational scale—on an average 30 filings a month, totaling more than 1000 lifecycle management cases. I work across Clinical/Non Clinical Dossier evaluation and Literature based submissions, including drug repurposing evaluation and strategy.

I deliver end-to-end regulatory dossier work including EU Lifecycle maintenance, renewal and update of product information based on safety updates, and CTD/NeeS/eCTD compilation. I lead module-based execution (EU Modules 1-5), provide documentation and quality management support, and ensure submissions align with EMA/ICH guidelines and CMDh recommendations.

I’ve also operated at management level and as an operational lead—driving regulatory excellence through team leadership, mentoring, and project management. Alongside submissions, I support scientific advice meetings, briefing packages, controlled correspondence, regulatory due diligence, and regulatory intelligence/competitive intelligence, including content creation and review for AI based database platforms.

Experience

Work history, roles, and key accomplishments

Current

Senior Regulatory Affairs Expert

Current

Silmed Scientific Pvt Ltd

Jun 2019 - Present (6 years 11 months)

Led global RA/CMC dossier development and regulatory strategy for marketing authorizations and lifecycle maintenance, supporting EU (DC/MR, CP, National Procedures) submissions. Managed EU lifecycle filings at scale, executing 500+ EU procedures and averaging ~30 variation filings per month across 1000+ lifecycle management cases.

Regulatory Affairs Regulatory Strategy EU Procedures (DC MR ECTD CTD NeeS Lifecycle Management Nitrosamine Genotoxic Risk Assessment

Director, Regulatory Affairs

ELC Group (Momajasro)

Jan 2016 - Jan 2019 (3 years)

Served as key expert in CMC, RA, and business development strategy, delivering dossier due diligence and complex regulatory report review for multinational clients across EU and global regions. Represented clients in agency discussions, supported scientific advice briefing packages, and provided options to address regulatory debates and questions.

Scientific Advice Briefing Packages Agency Interaction Support Regulatory Intelligence CTD ECTD NeeS Dossiers

Head of Regulatory Affairs

ELC Group (Momajasro)

Jan 2010 - Jan 2016 (6 years)

Managed a regulatory affairs team to ensure timely submission of marketing authorization applications through planning and project management. Led dossier compilation and review (CTD/eCTD/NeeS), managed EU variation/renewal and safety updates, and handled query responses across DCP/MRP/National procedures.

Regulatory Project Management Dossier Compilation (CTD ECTD NeeS)EU Lifecycle Maintenance (Variations Renewals)Query Response RFI Handling EU Procedures (DCP MRP National)Variation MA Transfer Management ECTD Work Practices

Research Associate, Regulatory Affairs

Astraon Research Ltd (Intas)

Jan 2006 - Jan 2008 (2 years)

Managed CMC dossier development and submission activities for highly regulated markets including EU, US, Canada, MCC, and Australia for oncology parenteral products. Prepared module 1–5 documentation in eCTD format, coordinated DCP submission activities, and maintained master document and DMF archives to support dossier compilation.

ECTD (Module 1 5)DMF Document Archiving DCP Procedures Compliance For EU US Canada Markets

Officer, Regulatory Affairs

Kopran Ltd

Jan 2004 - Jan 2006 (2 years)

Wrote, compiled, and supported dossier preparation for registration and re-registration in non-regulated markets, including Africa, Latin America, and APEC countries. Provided regulatory support for API and formulation submission activities to enable timely market filings.

Dossier API & Formulation Submission Support Market Filing Support

Regulatory Associate (CMC)

Novartis Healthcare Pvt Ltd

Jan 2008 - Present (18 years 4 months)

Implemented DP/DS CMC regulatory activities supporting lifecycle maintenance and renewals. Prepared drug product and drug substance quality documentation to support global regulatory submissions and communicate strategy aligned to commercial objectives.

CMC Writer Regulatory Submissions Regulatory Strategy