Jay Dhanawade
Ottawa,ON
Summary
Experienced professional specializing in regulatory affairs and analytical chemistry, with a strong track record in method validation, regulatory submissions, and quality management. Proficient in preparing and submitting DMF in CTD/eCTD formats, coordinating CMC documentation, and managing quality systems in compliance with global regulatory guidelines (ICH, USFDA, TGA, WHO, EDQM). Skilled in stability analysis, instrument troubleshooting, and handling technical data packages to ensure regulatory compliance and product quality. Additionally experienced in pharmacovigilance, managing safety data in Argus, conducting literature searches, and preparing adverse event narratives. Background in pharmacy assistance at Shoppers Drug Mart, supporting prescription processing, patient interaction, and efficient workflow in a fast-paced environment.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Pharmacy Assistant
Shoppers Drug Mart
11.2023 - Current
- Delivered exceptional service by greeting customers, gathering prescription information, managing wait times, and answering inquiries to ensure a positive patient experience.
- Handled data entry for new and refill prescriptions using HealthWatch software, prioritizing tasks based on the Role Assignment Schedule and Standard Operating Procedures to maintain an efficient workflow
- Assisted pharmacists with compounded medications by accurately measuring, mixing, and packaging ingredients in accordance with prescription specifications and compounding standards.
- Processed payments, managed the cash register, and adjudicated third-party billing claims, ensuring accuracy in insurance submissions and maintaining patient confidentiality.
- Prepared and submitted orders for prescription medications (excluding controlled substances), maintained accurate records of completed prescriptions, and ensured proper documentation for compliance with Pharmacy Standards of Practice.
Sr. Officer Regulatory Affairs
Mac-Chem Products Pvt. Ltd
08.2022 - 08.2023
- Coordinated CMC documentation for DMFs, ASMFs, and CEPs, ensuring alignment with regulatory standards (EU, ANVISA, MFDS, TFDA, EDQM).
- Prepared and submitted DMFs in CTD and eCTD formats for both regulated and semi-regulated markets
- Managed DMF-related queries and regulatory agency responses, working closely with HOD to address regulatory and customer inquiries.
- Reviewed and ensured compliance of technical data packages, BPCR & MOCR, and change control proposals with cGMP and regulatory guidelines (ICH, USFDA, TGA, WHO, ANVISA, EDQM).
- Utilized eCTD software (Knowledge Net, Lorenz e-validator) to manage submissions, ensuring accuracy and adherence to updated regulatory standards
Senior Research Associate
Piramal Pharma
05.2020 - 07.2022
- Conducted analytical method validation and transfer using HPLC, GC, and developed cleaning methods with UV and other analytical techniques, ensuring precision and regulatory compliance.
- Provided analytical support to the Synthesis Department, including reaction monitoring, stability analysis, and trend data reporting for APIs under development.
- Managed Quality Management Systems, including incidents, change control, and deviations, while addressing regulatory queries and maintaining accurate documentation for R&D and production.
Drug Safety Associate (Pharmacovigilance )
Tata Consultancy Services
04.2019 - 02.2020
- Submitted case reports to regulatory authorities within stipulated timelines and coordinated responses to safety-related queries and product complaints.
- Managed the Argus Safety Database, conducted literature searches, and prepared comprehensive narratives detailing medical history, drugs, and adverse events.
- Coded adverse events using MedDRA v20.1, ensured compliance with E2B R3 guidelines, and collaborated with regulatory authorities across various countries to support safe product submissions.
Education
Ontario College Graduate Certificate - Environmental Management & Assessment
Algonquin College
Ottawa, ON04-2025
Ontario College Graduate Certificate - Regulatory affairs
Algonquin College
Ottawa, ON04.2024
Masters - Analytical chemistry
S.D.S.M College, Mumbai University
01.2018
Bachelors - Chemistry
S.D.S.M College, Mumbai University
01.2016
Skills
- Training & Technical Support
- Observation
- Decision making
- Communication
- Multi-tasking
- Adaptability to change environment
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
Accomplishments
Shining Star Award For Project Paroxetine in 2020 in Piramal Pharma Solutions
Certification
- Post-Graduate Diploma in Regulatory Affairs From Institute of Pharmaceutical Management, Mumbai Completed With 73%
Interests
- Road Trips
- Adventure Travel
- I enjoy cooking for friends and family gatherings
- Food Photography
- Passionate about balancing physical health with mental and emotional wellness
- Playing Sports
Timeline
Pharmacy Assistant
Shoppers Drug Mart
11.2023 - Current
Sr. Officer Regulatory Affairs
Mac-Chem Products Pvt. Ltd
08.2022 - 08.2023
Senior Research Associate
Piramal Pharma
05.2020 - 07.2022
Drug Safety Associate (Pharmacovigilance )
Tata Consultancy Services
04.2019 - 02.2020
Masters - Analytical chemistry
S.D.S.M College, Mumbai University
Bachelors - Chemistry
S.D.S.M College, Mumbai University
Ontario College Graduate Certificate - Environmental Management & Assessment
Algonquin College
Ontario College Graduate Certificate - Regulatory affairs
Algonquin College
Similar Profiles
Rizul SukhijaRizul Sukhija
Front Store Supervisor at Shoppers Drug MartFront Store Supervisor at Shoppers Drug Mart
MELISSA SERRAMELISSA SERRA
Beauty Boutique Manager at Shoppers Drug MartBeauty Boutique Manager at Shoppers Drug Mart
Parham MoshiriParham Moshiri
Store Administrator at Shoppers Drug MartStore Administrator at Shoppers Drug Mart
Christo ThomasChristo Thomas
Front Store Assistant Manager at Shoppers Drug MartFront Store Assistant Manager at Shoppers Drug Mart
Bichara Mahamat AliBichara Mahamat Ali
Supervisor at McDonald'sSupervisor at McDonald's