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Independent Educational Work

Portfolio Project Plans

Planned scope, deliverables, and learning goals for projects across Regulatory Affairs and clinical research regulatory operations.

Status and representation

These projects are in development. They are not client work and are not represented as prior pharmaceutical, sponsor, CRO, clinical-trial, IRB, GCP, or health-authority submission experience.

In development · Regulatory Affairs

Regulatory Intelligence Brief

A concise, source-grounded analysis of a current FDA development and its possible implications for a regulatory team.

Planned deliverable

A two- to three-page brief covering the development, affected stakeholders, key dates, open questions, and practical monitoring considerations.

Capabilities demonstrated

Primary-source research, issue spotting, concise synthesis, transparent uncertainty, and audience-focused regulatory writing.

← Back to Regulatory Affairs projects
In development · Regulatory Affairs

Regulatory Pathway Memo

A structured analysis of possible U.S. development and submission pathways for a hypothetical small-molecule product.

Planned deliverable

A short memo defining assumptions, comparing plausible pathways, identifying information gaps, and recommending questions for further scientific and regulatory review.

Capabilities demonstrated

Legal and scientific issue framing, source hierarchy, assumption management, and clear separation of facts, analysis, and recommendations.

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In development · Regulatory Operations

eCTD Content Map

A hypothetical submission-content map organized around CTD modules, document purpose, ownership, status, and version control.

Planned deliverable

A spreadsheet-based map for a defined hypothetical submission scenario, including dependencies, responsible functions, document status, and QC fields.

Capabilities demonstrated

Information architecture, traceability, cross-functional planning, status visibility, and submission-readiness thinking—not eCTD publishing.

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In development · Regulatory Affairs

Labeling Comparison Matrix

A source-linked comparison of selected sections from FDA-approved product labels in one therapeutic area.

Planned deliverable

A matrix comparing indications, limitations, contraindications, warnings, and selected safety language, with citation and version-date fields.

Capabilities demonstrated

Close reading, controlled comparison, source traceability, version awareness, and concise presentation of material differences.

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In development · Regulatory Affairs

Promotional Review Exercise

An annotated review of hypothetical promotional content focused on claims, substantiation, context, and fair-balance considerations.

Planned deliverable

A fictional one-page item with line-by-line comments, a claims inventory, source references, and a short summary of major review issues.

Capabilities demonstrated

Claims analysis, evidence matching, precise annotation, risk identification, and collaborative review language.

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In development · Regulatory Affairs

Annotated Claims Packet

A mock administrative packet connecting hypothetical claims with supporting references, source locations, and review comments.

Planned deliverable

A claims table, reference index, annotated sources, and document-control fields prepared for an educational review scenario.

Capabilities demonstrated

Reference organization, annotation consistency, traceability, completeness checks, and review-ready presentation.

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In development · Documentation Quality

Good Documentation Practice SOP

A training-oriented procedure and QC checklist for clear, attributable, contemporaneous, and traceable records.

Planned deliverable

A concise SOP covering purpose, scope, roles, documentation expectations, corrections, review, retention, and a companion QC checklist.

Capabilities demonstrated

Procedure writing, logical sequencing, role clarity, review controls, and accessible training language.

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In development · Clinical Research Regulatory

Study Start-Up & Activation Tracker

A hypothetical site-level tracker for regulatory milestones, dependencies, ownership, dates, and escalation flags.

Planned deliverable

An Excel tracker for a fictional study site, with milestone definitions, planned and actual dates, status logic, document dependencies, owners, and notes.

Capabilities demonstrated

Workflow decomposition, data validation, status visibility, dependency tracking, and concise escalation reporting.

← Back to Clinical Research projects
In development · Clinical Research Regulatory

Essential-Document & Regulatory-Binder Map

A role- and timing-based map for organizing hypothetical study records and documenting completeness checks.

Planned deliverable

A document index grouped by study stage, with purpose, owner, expected timing, status, version date, and completeness-review fields.

Capabilities demonstrated

Document classification, traceability, lifecycle thinking, gap identification, and organized records review—not prior binder or TMF maintenance.

← Back to Clinical Research projects
In development · Clinical Research Regulatory

Protocol Amendment & IRB Impact Assessment

A change-impact worksheet identifying affected documents, review steps, stakeholders, and implementation controls for a hypothetical amendment.

Planned deliverable

A side-by-side amendment summary, affected-document list, stakeholder and communication matrix, approval dependencies, and implementation checklist.

Capabilities demonstrated

Change analysis, procedural mapping, stakeholder coordination, documentation control, and clear communication of downstream impacts.

← Back to Clinical Research projects