Dr. Payal Kalwar
Mumbai
Summary
Focused Project Manager adapt at planning, directing and maintaining continuous operations in various departments. Experienced in preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Skilled at identifying or anticipating problems and customer queries and providing solutions. Excels through mentoring, training and empowering team to excel in performance. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
3
3
years of professional experience
Work History
Project Manager
Invex Heath Pvt Ltd
05.2023 - Current
- Involved in mitigating risks, fostering strong partnerships, meticulous documentation, and aligning project objectives with our business strategy
- Experience in working with experts in the field of Oncology for B2B clients and online ecommerce platform for oncology medicines
- Coordinate internal resources and third parties/vendors for the flawless execution of projects
- Developing project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility
- Developing Project Budgets, Contracts and project lifecycle to meet the project objectives
- Preparing Project Artifacts (Project Charter, Meeting Agenda, Project Annual Reports etc.) and Improving implementation process
- Medical Devices like X-rays and Cath labs projects execution including AERB and CDSCO approvals to installation of the machine with post installation risk assessment and trainings
- Working with the Quality Assurance and Regulatory Affairs team to maintain strong risk assessment
- Co-ordination with sourcing and Logistics team for approvals and client requirements.
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Managed projects from procurement to commission for exports and tenders
Executive Regulatory Affairs and Project Management
RPG Life Science Ltd
06.2021 - 05.2023
- Interact with various administrative, legal & factory departments to collect documents required for regulatory compilation on time
- Dossier preparation for ROW and EU countries
- Review of documents from plant & providing guidance for revision of documents as per country guidelines in agreed timeframes
- Following up with MOH authority & customer for dossiers renewal & registration status
- Preparation of product query replies
- Development of artworks & labeling with text matters as per country requirement to artwork department
- Review of product labeling & Promotional Material.
- Conducted thorough reviews of labeling content for accuracy and adherence to relevant regulations before submission to authorities.
- Prepared and maintained document inventory for core dossier preparation.
Education
Doctor Of Philosophy - Chemistry
Mumbai University
KC College 06.2021
Master Of Chemistry - Analytical Chemistry
Wilson College
Mumbai 06.2015
Bachelor of Science - Chemistry
Patkar Varde College
Mumbai05.2013
Skills
- Research and Analysis
- Planning and Coordination
- Risk Management
- Business Strategy
- Quality Management
- Project Management
- Data management and Analysis
- Medical Device AERB approvals
- Regulatory Compliance for EU & ROW
- Adaptability and Resilience
- Strategic Planning
- Client Relations
- Stakeholder Communications
- Budgeting and forecasting
- Cross-Functional Collaboration
- Technical understanding
- Data Analysis
- Logistics Management
- Compliance Monitoring
Projects
Biplane Cath Lab Machine Turnkey Project of Hospital Nov-23- April 24
Demonstrated expertise in project planning, budgeting, and resource allocation, resulting in the successful delivery of the project within budget and ahead of schedule.
2.New Product Launch Naproxen Sodium for ROW market 2021-2023 Effectively managed project timelines, budgets, and resources to ensure timely market entry and meet business objectives and completed before timeline.
3.Dossier Submission to MOH for Europe Market Product: Sertraline 100mg Handled Client and MOH queries and successfully registered the product.
Personal Information
- Date of Birth: 01/03/93
- Gender: Female
- Marital Status: Married
Timeline
Project Manager
Invex Heath Pvt Ltd
05.2023 - Current
Executive Regulatory Affairs and Project Management
RPG Life Science Ltd
06.2021 - 05.2023
Doctor Of Philosophy - Chemistry
Mumbai University
Master Of Chemistry - Analytical Chemistry
Wilson College
Bachelor of Science - Chemistry
Patkar Varde College
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