Ronit Chen Email & Phone Number

Israel

Shoham, Center District, Israel

• Managing and writing submission documents for Approved Drug Products (Post Approval changes): Annual Reports, Supplements: PAS, CBE-0/30• Successfully responded to FDA inquiries and deficiency letters, ensuring compliance with FDA regulations.• Proficiency with all FDA Regulations. • Implemented and managed LEAN SIGMA project for process improvement of Annual Reports preparation, saving work time of 25%.

Bnei Brak, Tel Aviv District, Israel

• Writing DMFs for APIs for global markets: USA, Europe, Far East, Australia, etc.Responsibility for all DMF preparation stages: collecting, analyzing, processing and compiling the data into a DMF File, while constantly verifying data correctness and completion.• Maintenance of DMF files, in alignment with the health authorities requirements.• Successfully responded to FDA inquiries and deficiency letters.• Providing responses to customers' demands, while keeping company`s… Show more • Writing DMFs for APIs for global markets: USA, Europe, Far East, Australia, etc.Responsibility for all DMF preparation stages: collecting, analyzing, processing and compiling the data into a DMF File, while constantly verifying data correctness and completion.• Maintenance of DMF files, in alignment with the health authorities requirements.• Successfully responded to FDA inquiries and deficiency letters.• Providing responses to customers' demands, while keeping company`s interests.• Working with various departments within the company (R&D laboratories, pilot, QA, QC, outsourcing, sales and marketing). Show less

Bachelor'S Degree, Chemistry

Bagrut, Chemistry