RATI BHATT
Toronto,ON
Summary
A result-driven Regulatory Affairs professional with a strong background in ensuring compliance with regulatory guidelines. Skilled in utilizing eCTD software for efficient regulatory submissions and maintaining adherence to industry standards. Experienced in analyzing and updating regulatory affairs guidelines to meet compliance requirements.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Technical Officer
Supreme Pharma Healthcare Pvt. Ltd,
Mumbai, INDIA
06.2022 - 07.2023
- Prepared regulatory submissions including authorizing and reviewing by FDA Regulations.
- Documentation and Submissions for electronic submissions.
- Accurately, Assess, collects, Analysis and reports of data.
- Preparing Dossiers of French West African Countries, Myanmar, Uganda, Central America.
- Preparation Purchase Order, Proforma Invoice, Packing List also responding to queries raised by MOH.
- Legalize documents as per country requirement.
Intern
Renumed Pharmaceutical
Palghar, IND
05.2021 - 12.2021
- Assisted in conducting comprehensive quality checks and inspections on streptomycin sulfate capsule production lines.
- Acquired familiarity with regulatory requirements such as 21 CFR 211, GMP, Drug Master File (DMF), and dossier compilation specific to the manufacturing and quality assurance of streptomycin sulfate capsules.
- Maintained technical documentation for devices used for quality control and validation, SOP analysis.
Education
Masters in Regulatory Affairs
Northeastern University
Toronto, ON09-2025
Bachelor of Pharmacy
Dr. Bhanuben Nanavati College of Pharmacy
India, Mumbai05-2022
Skills
- Regulatory Submissions (eCTD)
- FDA Regulations and Compliance
- Documentation Management
- International Regulatory Requirements
- Pharmaceutical Manufacturing Standards (GMP)
- SOP Development
- Data Analysis
Soft Skills:
- Communication
- Problem -Solving
- Analytical Thinking
- Adaptability
- Leadership
Certification
- Successfully completed online training on Cyber Security – Digital Forensics & Cyber Law conducted by Government of India Organization India in May 2023.
- Internationally Accredited Diploma Certificate Course on Nutrition offered by Udemy in May 2020.
Projects
- Preparation of an application for the Registration of an International Patent as per the Patent Cooperation Treaty (PCT), Northeastern University, MAY 2024- JUN 2024
- Assignment 510K Pathway , Northeastern University ,Sept 2023– Dec 2023 Spearheaded the preparation of a comprehensive 510(k) submission for a pulse oximeter.
- Thesis-based project on “Evaluation and Study of Anti- Inflammatory Topical Formulation” Dr Bhanuben Nanavati College of Pharmacy, Jan 2022 - MAY 2022.
Timeline
Technical Officer
Supreme Pharma Healthcare Pvt. Ltd,
06.2022 - 07.2023
Intern
Renumed Pharmaceutical
05.2021 - 12.2021
Masters in Regulatory Affairs
Northeastern University
Bachelor of Pharmacy
Dr. Bhanuben Nanavati College of Pharmacy
- Successfully completed online training on Cyber Security – Digital Forensics & Cyber Law conducted by Government of India Organization India in May 2023.
- Internationally Accredited Diploma Certificate Course on Nutrition offered by Udemy in May 2020.
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