Resume

Dhirajkumar Arvind Nangare

Taloja Phase 2, Navi Mumbai-410208
Email: dhirajkumarnangare25@gmail.com
Phone: 7767884107

Objective:
To secure a responsible career opportunity in a reputable organization that will allow me to utilize and
improve my training and skills. I aim to contribute to the achievement of organizational goals and offer my
services to ensure better and more effective healthcare for patients.

Work Experience:
Regulatory Affairs Associate (Apprenticeship)
Alkem Laboratories, Navi Mumbai, India
Jan 2023 - Current

Key Skills:
➢ Dossier Preparation for Global Market: Proficient in preparing regulatory dossiers for global
market submissions, ensuring compliance with international regulations and guidelines.
➢ Regulatory Query Responses and COPP Application: Timely and accurate submission of
responses to regulatory queries.
➢ Variation Filing in Global Regulatory Affairs: Experienced in managing and filing regulatory
variations across multiple markets.
➢ Artwork Update: Coordinating and executing artwork updates for product packaging, meeting
regulatory requirements and branding standards.
➢ SAP NetWeaver: Skilled in utilizing SAP NetWeaver for data management and process integration.
➢ Electronic Document Management System (EDMS): Proficient in organizing, storing, and
retrieving regulatory documents.
➢ TrackWise: Familiar with quality management software for tracking and managing compliance
activities.
➢ Adobe Acrobat: Competent in document creation, editing, and conversion.
➢ Abbreviated New Drug Application (ANDA): Experienced in preparing and submitting
applications in accordance with FDA regulations.

Education:
➢ M. Pharmacy, Dr. Babasaheb Ambedkar Technological University, Lonere (Raigad), 2022
(Distinction)
➢ B. Pharmacy, Shivaji University, Kolhapur, 2020 (Distinction)
➢ HSC, Maharashtra State Board of Secondary & Higher Secondary Education, 2016 (Second)
Co-Curricular Activities:
➢ Participated in the 4th Annual Conference of Society for Alternatives to Animal Experiments –
INDIA (SAAE-1).
➢ Attended the First international webinar series on “Artificial Intelligence in drug discovery.”
➢ Participated in the 71st INDIAN PHARMACEUTICAL CONGRESS with the theme: "Healthcare
System - Role of Modulators."
➢ Attended the National Conference "Pharmacovigilance: a key for drug safety management."

Key Strengths:
➢ Smart Working
➢ Ability to work in a team and individually.
➢ Quick learner

Personal Information:
➢ Name: Dhirajkumar Arvind Nangare
➢ Date of Birth: 15/06/1998
➢ Gender: Male
➢ Nationality: Indian
➢ Languages known: English, Hindi, and Marathi

Declaration:

I hereby state that all the above information is true to the best of my knowledge.

Dhirajkumar Nanagre.