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Pradnya Bamne
Regulatory Affairs
Mumbai
Summary
Regulatory Affairs Officer experienced in developing effective processes and executing regulatory affairs initiatives for pharmaceutical, nutraceutical and medical devices industry. Improved processes and assisted product development in meeting regulatory requirements. Maintained and followed up on records of regulatory information and submissions in ROW market.
Enthusiastic regulatory personnel eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of dossier preparation (ACTD and CTD) Motivated to learn, grow and excel in product compliance. Learned and continuously researched regulatory requirements for Pharma industry to maintain compliance. Collaborated with internal and external teams to develop transparent, efficient processes.
Overview
4
4
years of professional experience
6
6
years of post-secondary education
Work History
Officer
Brooks Laboratories Limited
Mumbai
01.2022 - Current
- Held training sessions to improve Data management Skills in the Team for Regulatory documentation.
- Devised and deployed techniques for obtaining earliest possible approval for each product.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Prepared and maintained document inventory for core dossier preparation.
- Consolidated global information relevant to pharmaceutical products and monitored global submissions and approvals status.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
- Directed documentation efforts to comply with domestic and international regulations and standards.
- Provided responses to regulatory agencies regarding product information or issues.
- Analyzed field studies and reports, compiled information and submitted concise and informative summaries.
- Consulted with regulatory representatives to manage filings, applications and reports.
- Managed fees and applications, tracked product progress, liasoning documentation updates and handled all responses to regulatory inquiries.
- Recommended improvements to regulatory registration processes ROW market.
- Performed and documented quality control checks to maintain compliance with company initiatives.
Executive -Regulatory Officers
Cupid Limited
Mumbai
08.2022 - 01.2023
- Conducted regular meetings with team to discuss issues, concerns and updates.
- Introduced new methods, practices and systems to reduce turnaround time.
- Identified trends and assessed opportunities to improve processes and execution.
- Contributed with the regulatory assistance with the sister firms Seloi Healthcare and Invex private limited.
- Utilized appropriate financial tools to manage accounts payable and receivable.
- Assisted with product artwork designs and for brochure designing business exhibitions
Executive Trainee - Regulatory Affairs
Meril Lifesciences private limited
Mumbai
02.2021 - 06.2022
- Assigned with the CIS and Russia team for Medical devices registration and query handling
- Assisted with compliance reports making for audits
- Conducted regular meetings with team to discuss issues, concerns and updates.
- Introduced new methods, practices and systems to reduce turnaround time.
- Trained for Liasoning of administrative documents for registration purpose
Education
Post Graduate Diploma - Quality Assurance in Foods And Pharmaceuticals
08.2019 - 12.2020
Bachelor of Science - Biotechnology
07.2016 - 03.2019
HSC - Science Education
08.2014 - 04.2016
Skills
Microsoft Office
Interests
Nutrition
Reading
Music
Timeline
Executive -Regulatory Officers - Cupid Limited
08.2022 - 01.2023
Officer - Brooks Laboratories Limited
01.2022 - Current
Executive Trainee - Regulatory Affairs - Meril Lifesciences private limited
02.2021 - 06.2022
Sophia Women's College - Post Graduate Diploma, Quality Assurance in Foods And Pharmaceuticals
08.2019 - 12.2020
VIVA College - Bachelor of Science, Biotechnology
07.2016 - 03.2019
VIVA Junior College - HSC, Science Education
08.2014 - 04.2016
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