Khushi Naik

KN

Open to opportunities

Khushi Naik

@khushinaik

Regulatory Affairs and Quality professional focused on generic dossiers, GMP documentation, and USFDA/EU compliance.

What I'm looking for

I’m looking for an entry-level role in Regulatory Affairs/Quality where I can support generic drug dossier preparation, regulatory documentation review, and GMP-oriented QA/QC activities, while building deeper experience with USFDA and EU compliance.

I’m a Regulatory Affairs and Quality professional with academic and internship experience supporting pharmaceutical regulatory documentation, quality control/QA-QC workflows, and generic drug dossier preparation. I build my work around documentation accuracy, analytical quality practices, and GMP-compliant expectations across regulated environments.

In my QC Intern role at Gufic Biosciences, I supported analytical testing and quality documentation under QC supervision, observing processes for raw materials, in-process samples, and finished product testing while maintaining awareness of data integrity and GMP practices. Previously, at Centurion Remedies, I assisted QA/QC activities including documentation review and record maintenance to strengthen my understanding of quality systems and compliance. Alongside this, my Master’s work included preparation of a draft dossier for a generic sorafenib tablet per USFDA guidance and a comparative study of US vs EU regulatory requirements, alongside exploration of artificial intelligence in drug discovery and development.

Experience

Work history, roles, and key accomplishments

GL

QC Intern

Gufic Biosciences Limited

Aug 2025 - Jan 2026 (5 months)

Supported analytical testing and QC documentation activities under supervision in a pharmaceutical manufacturing setting, observing workflows for raw materials, in-process samples, and finished product testing. Maintained focus on documentation accuracy, data integrity, and GMP-compliant laboratory practices.

Analytical Laboratory GMP Compliance Data Integrity In Process Testing Finished Product Testing

CL

Quality Analytics Intern

Centurion Remedies Pvt. Ltd.

Jan 2023 - May 2023 (4 months)

Assisted QA/QC efforts involving pharmaceutical quality documentation and analytical operations, supporting documentation review and record maintenance. Gained exposure to QA/QC systems, compliance practices, and GMP-oriented documentation control in a regulated setting.

Record Maintenance Documentation Review Compliance Support Quality Systems Documentation Control Quality Analytics

Education

Degrees, certifications, and relevant coursework

AC

Anand Pharmacy College

Master's degree in Drug Regulatory Affairs, Drug Regulatory Affairs

Activities and societies: Academic projects: Draft dossier for generic Sorafenib tablet (USFDA guidance); comparative study of regulatory requirements (USA vs European Union); AI in drug discovery and development.

Completed a Master’s in Drug Regulatory Affairs, including a project drafting a generic sorafenib tablet dossier per USFDA guidance and a comparative study of US and EU regulatory requirements.

SV

Sumandeep Vidyapeeth

Bachelor of Pharmacy, Pharmacy

Activities and societies: Academic project: Formulation and characterization of a wound healing spray (SSIP).

Completed a Bachelor of Pharmacy with academic projects including formulation and characterization of a wound healing spray (SSIP).

Tech stack

Software and tools used professionally

Gmail

Jan

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