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Dhwani User

@dhwaniuser

I prepare and review pharmaceutical regulatory documents for accurate submissions.

India
Message

What I'm looking for

I'm seeking opportunities in Regulatory Affairs, Clinical Documentation, Regulatory Operations, or entry-level Pharmacovigilance where I can apply my regulatory documentation, review, and submission preparation experience.

At Briyosis Soft Caps Pvt. Ltd., I prepared and reviewed pharmaceutical regulatory documents including FSSAI permissions, Free Sale Certificates, Product Data Reports, SMPCs, COPPs, Product Permissions, and NOCs.

I've drafted regulatory applications through the FoSCoS portal, prepared documents through the IFP Portal, and reviewed product artwork, labels, and submission files for accuracy and completeness. I also coordinate with internal departments to collect and verify required regulatory information.

As a Bachelor of Pharmacy graduate, I'm building on my regulatory documentation experience through training in Good Clinical Practice, medical-product regulation, and drug safety and pharmacovigilance.

Experience

Work history, roles, and key accomplishments

BL

Regulatory Affairs Trainee

Briyosis Soft Caps Pvt Ltd

Mar 2025 - Apr 2026 (1 year 1 month)

Prepared regulatory documentation including FSSAI permissions, Free Sale Certificates, Product Data Reports, and Summary of Product Characteristics. Reviewed documents and coordinated with internal departments to ensure accuracy and completeness.

Education

Degrees, certifications, and relevant coursework

SP

Sigma Institute of Pharmacy

Bachelor of Pharmacy, Pharmacy

Grade: 6.70 CGPA

Bachelor of Pharmacy degree from Sigma Institute of Pharmacy, affiliated with Gujarat Technological University, completed in 2024 with a CGPA of 6.70.

Tech stack

Software and tools used professionally

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