Patel Gargi Kevalkumar
Kitchener,ON
Summary
Adept Regulatory Affairs Officer with a proven track record at Farbe Firma Private Limited, excelling in global regulatory compliance and fostering robust communication channels. Spearheaded strategies for timely regulatory approvals, significantly enhancing project efficiency. Expertise in documentation management and adept at navigating international regulations, ensuring top-notch service and regulatory adherence.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Officer
Farbe Firma Private Limited
Ankleshwar, Bharuch Gujarat
05.2022 - 10.2024
- Observed and monitored contracts with outside suppliers to deliver regulatory support.
- Reviewed the labeling of the products for accuracy and compliance with applicable regulations, and also prepared the PIL and leaflet.
- Established procedures or systems for publishing document submissions in hardcopy or electronic formats.
- Worked with regulatory bodies to negotiate filings, complete applications and report changes.
- Collaborated with cross-functional teams, such as Quality Assurance, Manufacturing, and Packaging, to ensure compliance with relevant regulations.
- Submitted fees and applications, tracked product permissions and COPPs status updates, and handled all correspondence during regulatory affairs processes.
- Managed upkeep of regulatory electronic and hard copy filing systems and archives.
- Prepared technical documents, including the Summary Technical Document and Design Dossier.
- Assisted in the preparation of responses to queries from regulatory agencies concerning product registration applications.
- Participated in audits conducted by external organizations such as Notified Bodies or Regulatory Agencies.
- Maintained records of approved documents for all registered products according to local laws or international standards.
- Ensured timely submission of annual reports required under various jurisdictions.
- Audited suppliers' documentation systems for quality assurance purposes.
- Evaluated changes to documents submitted to determine need for amendments.
- Created reports summarizing regulatory submissions status, timelines and other key information related to projects.
- Developed, maintained and updated procedures for registration of products in different countries.
- Provided regulatory guidance and advice to the organization on applicable regulations.
- Collaborated with cross-functional teams to interpret and communicate new and revised laws.
- Completed day-to-day duties accurately and efficiently, attended the meetings, and updated the daily work.
- Managed time effectively to ensure tasks were completed on schedule and deadlines were met.
- Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
- Provided excellent service and attention to customers when face-to-face or through phone conversations.
- Demonstrated strong problem-solving skills, resolving issues efficiently and effectively.
- Identified needs of customers promptly and efficiently.
Quality Assurance Analyst
ACE Laboratories
Ankleshwar, Bharuch Gujarat
05.2021 - 05.2022
- Reviewed the Standard Operating Procedures.
- Archived and maintained the documents manually and virtually.
- Reviewed the finished product and active product certificate of analysis.
- I also prepared the stability reports.
- Maintained self-study program to enhance QA knowledge and skills.
- Prepared and analyzed internal and external quality reports for management staff review.
- Documented, triaged, and managed defects in software and worked with developers to facilitate timely resolutions.
- Prepared analytical validation protocols and reviewed overall report progress according to established timelines.
- Participated in daily scrum meetings providing status updates on projects assigned.
- Coordinated with product management to understand feature requirements and ensure testing coverage.
- Implemented internal auditing practices to create standards and statutory obligation compliance reports.
- Worked with co-members to create efficient workflows, resulting in high productivity.
- Conducted internal audits to measure adherence to established QA standards.
- Maintained policy, procedures, work instructions, and projects for quality and continuous improvement agendas.
- Communicated regularly with head of department to discuss quality trends.
- Worked with cross-functional teams to achieve goals.
- Maintained updated knowledge through continuing education and advanced training.
Education
Masters - Regulatory Affairs
Ramanbhai Patel College of Pharmacy, CHARUSAT
Changa, Nadiad, Gujarat, India05-2022
Bachelor - Pharmacy
Shree Dhanvantary Pharmacy College
Kim, Surat, Gujarat, India04-2019
Ph.D. - Regulatory Affairs
Bhagwan Mahavir University
Surat, Gujarat, IndiaSkills
- Documentation management
- Regulatory submissions
- Regulatory agency applications
- International regulations
- Global regulatory compliance
- Good communication
Certification
- Had participated in 4th International conference on "Theranostic Nanoparticles: A recent breakthrough in Nanotechnology" organized by Shree Dhanvantary Pharmacy College"
- Participated in Akhil Bharatiya Vidhyarthi Parishad i.e 9th Pharma Vision for Poster Presentation entitled as " Comparision of Stability Data Requirement for filing drug product in USA & India"
- Participated in Seminar organized by RPCP, CHARUSAT,Changa entitled "IPR ENABLED".
Timeline
Regulatory Affairs Officer
Farbe Firma Private Limited
05.2022 - 10.2024
Quality Assurance Analyst
ACE Laboratories
05.2021 - 05.2022
Masters - Regulatory Affairs
Ramanbhai Patel College of Pharmacy, CHARUSAT
Bachelor - Pharmacy
Shree Dhanvantary Pharmacy College
Ph.D. - Regulatory Affairs
Bhagwan Mahavir University
Similar Profiles
Gringeri WalterGringeri Walter
Revenue Manager at Vito Ditta Ag (Private firma selling products such as bags end touristic itemsRevenue Manager at Vito Ditta Ag (Private firma selling products such as bags end touristic items
Caecilia Dwiyanti YeoCaecilia Dwiyanti Yeo
Director at Terra Firma Group LimitedDirector at Terra Firma Group Limited
Rosemarie GassnerRosemarie Gassner
Jewellry Designer/Small Business Owner at Farbe DesignJewellry Designer/Small Business Owner at Farbe Design