Windsor, CT nandhishn@gmail.com LinkedIn Available for On-Site & Remote Roles

Career Direction

Regulatory Affairs & Regulatory Operations

I am pursuing associate- and coordinator-level roles where legal analysis, scientific literacy, documentation discipline, project coordination, and careful review can support regulated product development.

The fit

Regulatory Affairs sits at the point where evidence, requirements, documentation, and coordinated execution meet.

Regulatory research & writing

Legal training supports close reading of statutes, regulations, guidance, and complex fact patterns, along with concise and defensible written analysis.

Scientific literacy

Molecular and cell biology and chemistry training support communication with technical contributors and understanding of product-development evidence.

Documentation & traceability

Judicial records, laboratory notebooks, technical reporting, and procedural work reinforce completeness, version awareness, and review readiness.

Operations & coordination

Project reporting, Excel/VBA automation, stakeholder coordination, and audit support provide a foundation for submission planning and workflow tracking.

Roles of interest

Titles vary by company; these are the entry-level role families for which I am positioning.

Regulatory Affairs Coordinator Regulatory Affairs Associate I Regulatory Operations Associate Regulatory Submissions Coordinator Regulatory Documentation Specialist Regulatory Intelligence Support Lifecycle Management Support

Current preparation

  • Enrolled in the University of Maryland School of Pharmacy M.S. in Regulatory Science, beginning August 2026.
  • RAPS Fundamentals of Regulatory Affairs credentials in pharmaceuticals and medical devices.
  • Entry to Regulatory course with case-based regulatory work-product drafting emphasis.
  • Independent portfolio plans covering regulatory intelligence, pathway analysis, labeling, promotional review, and eCTD content mapping.

What I am prepared to support

  • Regulatory research, issue spotting, and clear synthesis.
  • Document intake, organization, QC, tracking, and version discipline.
  • Cross-functional timelines, status reporting, and follow-up.
  • Submission-readiness support under established procedures and supervision.

Transparent positioning

Portfolio items are independent educational work products or plans. They are not represented as client work, completed health-authority submissions, eCTD publishing experience, or prior pharmaceutical-industry experience.

Review the Regulatory Affairs resume

This version emphasizes regulatory research, documentation, submission support, and product-development alignment.

Open PDF Resume