Kamini Pore
Mumbai
Summary
With over 20 years of professional experience, I have a strong background in both Executive Assistance and Established Pharmaceutical Division - Regulatory Affairs. In my 10 years as an Executive Assistant, I have honed my organizational skills and ability to support senior management effectively. Responsibilities catered and collaborative approach as an Executive assistance helped me achieve a promotion to work in a diverse role for Regulatory Affairs Operations Team as an “Associate Registration Management (System Coordinator” Additionally, my 10 years in Regulatory Affairs have equipped me with a deep understanding of compliance and regulatory requirements globally. I am adept at managing multiple tasks, prioritizing deadlines, and ensuring seamless operations. I am confident that my diverse skill set, and experience make me an asset to any organization.
Overview
18
18
years of professional experience
Work History
ASSOCIATE – REGISTRATION MANAGEMENT
Abbott
Mumbai
10.2016 - Current
- Accountable for maintenance of RIMS (Regulatory Information Management System) database in line with Standard Operating Procedures (SOP) and user guides applicable for Global Regulatory Operations principally regulatory affairs data management and life cycle maintenance activities by coordinating with cross functional teams
- Execution of quality control checks to meet required standards for data maintenance in regulatory affairs system
- Ensure quality data input in regulatory affairs system
- Distribution of updates to Company Core Data Sheets (CCDS) and Reference Label using a Source Document Change Notification (SDCN) and tracking in regulatory affairs system
- Submit data elements to European Medicines Agency (EMA) related to Extended EudraVigilance medicinal product dictionary (XEVMPD) according to agency requirements
- Responsible for timely creation, compilation, and distribution of reports primarily Product Quality Report (PQR) and Worldwide Marketing Authorization Status (WWMAS) report and Ad hoc reports as applicable from Regulatory Affairs system
- Responsible for testing and validation of software enhancements and releases.
DEPARTMENT ASSISTANCE - GLOBAL REGULATORY AFFAIRS TEAM
Abbott
Mumbai
10.2013 - 09.2016
DEPARTMENT ASSISTANT - PROJECT MANAGEMENT OFFICE
Abbott
08.2012 - 10.2013
SENIOR EXECUTIVE ASSISTANCE
Gammon India
Mumbai
06.2007 - 08.2012
- Provided high-level administrative support to executives Directors, manage calendars, coordinate meetings, and handle confidential information with discretion
- Strong communication and organizational skills, along with proficiency in Microsoft Office and experience in a similar role
- Project Management Office (PMO) department as the preliminary role responsibilities
- Assisting seniors in compiling monthly dashboards
- Data management for the managerial presentations
- Preparing Gantt charts for tracking various business units' activity weekly
- Other administrative functions.
Education
API & Formulation -
Indian Institute of Pharmaceutical Management
03.2023
Diploma in Management studies -
Indira Gandhi National Open University
03.2010
Bachelor of Commerce -
University of Mumbai
06.2001
Skills
- Regulatory Affairs System Coordinator
- DARIUS
- Data Management
Accomplishments
- Executing Intrapreneurship skills from Vision to Reality as “Cultural Champion”
- Enduring - Affiliate Support for India, APAC, and China region.
- Hormone Registered Position Building Project for Hormone and Clarithromycin
- Thai eCTD migration
- EPD Divisional Audit of GRA
- Collaboration - Cross Functional Training
- Achieving - DARIUS 2.0 - UAT execution support, 2022, Mumbai
Roles And Responsibilities
- ASSOCIATE – REGISTRATION MANAGEMENT, 10/2016, Current, Abbott, Mumbai, Accountable for maintenance of RIMS (Regulatory Information Management System) database in line with Standard Operating Procedures (SOP) and user guides applicable for Global Regulatory Operations principally regulatory affairs data management and life cycle maintenance activities by coordinating with cross functional teams, Execution of quality control checks to meet required standards for data maintenance in regulatory affairs system, Ensure quality data input in regulatory affairs system, Distribution of updates to Company Core Data Sheets (CCDS) and Reference Label using a Source Document Change Notification (SDCN) and tracking in regulatory affairs system, Submit data elements to European Medicines Agency (EMA) related to Extended EudraVigilance medicinal product dictionary (XEVMPD) according to agency requirements, Responsible for timely creation, compilation, and distribution of reports primarily Product Quality Report (PQR) and Worldwide Marketing Authorization Status (WWMAS) report and Ad hoc reports as applicable from Regulatory Affairs system, Responsible for testing and validation of software enhancements and releases.
- DEPARTMENT ASSISTANCE - GLOBAL REGULATORY AFFAIRS TEAM, 10/2013, 09/2016, Abbott, Mumbai
- DEPARTMENT ASSISTANT - PROJECT MANAGEMENT OFFICE, 08/2012, 10/2013, Abbott
- SENIOR EXECUTIVE ASSISTANCE, 06/2007, 08/2012, Gammon India, Mumbai, Provided high-level administrative support to executives Directors, manage calendars, coordinate meetings, and handle confidential information with discretion, Strong communication and organizational skills, along with proficiency in Microsoft Office and experience in a similar role, Project Management Office (PMO) department as the preliminary role responsibilities, Assisting seniors in compiling monthly dashboards, Data management for the managerial presentations, Preparing Gantt charts for tracking various business units' activity weekly, Other administrative functions
Timeline
ASSOCIATE – REGISTRATION MANAGEMENT
Abbott
10.2016 - Current
DEPARTMENT ASSISTANCE - GLOBAL REGULATORY AFFAIRS TEAM
Abbott
10.2013 - 09.2016
DEPARTMENT ASSISTANT - PROJECT MANAGEMENT OFFICE
Abbott
08.2012 - 10.2013
SENIOR EXECUTIVE ASSISTANCE
Gammon India
06.2007 - 08.2012
API & Formulation -
Indian Institute of Pharmaceutical Management
Diploma in Management studies -
Indira Gandhi National Open University
Bachelor of Commerce -
University of Mumbai
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