Nikhil Negi

About Nikhil Negi

Master’s in Pharmaceutics with strong experience in ICH guidelines, DMF preparation, dossier compilation and submissions, and regulatory documentation for pharmaceutical products Solid working knowledge of medical device regulatory requirements under 21 CFR Part 820, including Quality Management Systems (QMS) Experienced in document control, design controls, production and process controls, and nonconforming product management for medical devices Knowledgeable in identification and traceability, CAPA, and handling, storage, and distribution requirements to ensure compliance and product integrity Strong understanding of how device labeling and traceability support effective recalls, regulatory compliance, and patient safety Skilled in GDP practices, Artwork/FPS review, BE/CDP requirements, and generic regulatory pathways for ROW markets Well-versed in end-to-end drug regulatory workflows, master document management, and advanced use of Excel for regulatory tracking, data handling, and documentation support

Experience

1. Regulatory Affairs Trainee

   Genedrift

   Sep 2025 — Present · IN

   Supported medical device quality system activities in alignment with ISO 13485 and 21 CFR Part 820• Assisted in CAPA documentation, root cause analysis, and effectiveness checks• Reviewed device labelling and traceability documentation to support recall readiness and patient safety• Performed document adequacy and compliance checks to ensure regulatory and audit readiness• Maintained master documents, ensuring version control, traceability, and lifecycle compliance• Drafted, reviewed, and updated SOPs in line with QMS and regulatory requirements• Supported regulatory submissions through dossier compilation, documentation review, and query response coordination• Adequacy & Qualitative Review: Reviewed regulatory dossiers for completeness, accuracy, consistency, and compliance with CTD/ACTD, ICH, WHO, and FDA requirements.• DMF Review: Evaluated Drug Master Files for API manufacturing process, specifications, stability data, and GMP compliance.• CMC Review: Assessed CMC documentation including formulation development, manufacturing process, control strategy, validation, and stability studies.• Master Document Review: Reviewed and maintained master documents ensuring version control, traceability, and lifecycle compliance.• SOP Development: Drafted, reviewed, and updated SOPs in line with regulatory and quality system requirements.• FPS & Artwork Review: Verified finished product specifications, labelling/artworks, registration certificates, and vendor documents for regulatory conformity.• Dossier Preparation: Compiled and supported regulatory dossiers and submissions ensuring accuracy and audit readiness.

Education

• Shri Guru Ram Rai P.G College, Dehradun

  Bachelor of Pharmacy - BPharm, Pharmacy

  2019 — 2023

• Shri Guru Ram Rai University

  Bachelor of Pharmacy

• Kumaun University (KU), Nainital

  Master's degree, Pharmaceutical Sciences