Jay Dhanawade

Pharmacy Assistant and Regulatory Affairs professional

Nepean, OttawaMember since June 8, 2024

Prescription processingCompounding supportThird-party adjudicationPharmacy operationsRegulatory AffairsPharmacovigilanceDrug SafetyGlobal regulatory submissionsAdverse event reportingDMFsASMFsCEPsCTD/eCTD formatsAnalytical validation reviewStability studiesImpurity assessmentscGMP guidelinesLorenz e-validatorKnowledge NetArgus Safety DatabaseHealth-Watch softwareHPLCGCMed-DRA v20.1

About

Pharmacy Assistant and Regulatory Affairs professional with hands-on experience in prescription processing, compounding support, third-party adjudication, patient service, and pharmacy operations while maintaining high standards of compliance and accuracy. Experienced in Regulatory Affairs, Pharmacovigilance, and Drug Safety, including global regulatory submissions, case processing, adverse event reporting, and compliance with regulatory guidelines. Skilled in preparing and reviewing DMFs, ASMFs, and CEPs in CTD/eCTD formats for regulated and semi-regulated markets including EU, USFDA, ANVISA, MFDS, TFDA, and EDQM.

Knowledgeable in analytical validation review, stability studies, impurity assessments, and compliance with ICH and cGMP guidelines. Proficient in eCTD tools such as Lorenz e-validator, Knowledge Net, and Argus Safety Database.

Experience

Pharmacy Assistant - Shoppers Drug Mart Store No 627 - Ottawa

(2023-11 - 2025-05)

Part Time position from 11/2023 to 05/2025; Full Time from 05/2025 to Present

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 Health-Watch 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 India Pvt. Ltd - Mumbai, India

(2022-08 - 2023-08)

Coordinated CMC documentation for DMFs, ASMFs, and CEPs, ensuring alignment with regulatory standards (EU, ANVISA, MFDS, TFDA, and 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 - Mumbai, India

(2020-05 - 2022-07)

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 - Mumbai, India

(2019-04 - 2020-02)

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 Med-DRA v20.1, ensured compliance with E2B R3 guidelines, and collaborated with regulatory authorities across various countries to support safe product submission.