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Rutika Patil

@rutikapatil2

Regulatory Affairs Associate at Pharmonix Biological, supporting CTD/CMC dossiers and submissions across US, EU, and Indian markets.

India
Message

At Pharmonix Biological Pvt. Ltd., I supported regulatory documentation and dossier work for pharmaceutical excipients and formulations across US, EU, and Indian markets. I reviewed and coordinated CTD/CMC documents to help keep submissions accurate, complete, and ready to file.

I prepared technical documentation in line with ICH, USFDA, EMA, CDSCO, and pharmacopoeial requirements. I also supported DMF documentation and responses to customer and health-authority technical queries.

At Zurain Enterprises Pvt. Ltd., I prepared and compiled DMF and CTD documentation and supported dossier reviews and submission activities. I also assisted with CDSCO filings through the SUGAM portal.

My pharmacy and production experience includes managing pharmacy operations at AAP (Apna Ayush Pharma) and gaining exposure to pharmaceutical manufacturing and quality control during internships. For my Herbal Hand Wash Tablet project, I performed stability and efficacy testing.

Experience

Work history, roles, and key accomplishments

PL

Regulatory Affairs Associate

Pharmonix Biological Pvt. Ltd.

Sep 2025 - Sep 2026 (1 year)

Managed global regulatory documentation and dossier support for pharmaceutical excipients and formulations across US, EU, and Indian markets. Reviewed and coordinated CTD/CMC documentation, prepared regulatory documents per ICH, USFDA, EMA, and CDSCO, and supported DMF documentation and regulatory compliance activities.

ZL

Regulatory Affairs Intern

Zurain Enterprises Pvt. Ltd.

Apr 2025 - Jul 2025 (3 months)

Prepared and compiled DMF and CTD regulatory documentation in accordance with CDSCO and USFDA requirements. Supported regulatory dossier preparation, document review, and submission activities, and assisted with CDSCO filings through the SUGAM portal.

Education

Degrees, certifications, and relevant coursework

MP

MET College of Pharmacy

Bachelor of Pharmacy, Pharmacy

2022 - 2025

Pursued a Bachelor of Pharmacy with a specialization in Regulatory Science and Pharmaceutical Marketing.

BP

Bharati Vidyapeeth College of Pharmacy

Diploma in Pharmacy, Pharmacy

2019 - 2021

Completed a Diploma in Pharmacy.

RC

Ramanand Arya DAV College

Higher Secondary Certificate, General Studies

2018 - 2019

Completed Higher Secondary Certificate (HSC).

Tech stack

Software and tools used professionally

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