Open To Work
Hi, I’m
SHWETA PRAJAPATI
Vancouver
Summary
I am a Regulatory Affairs professional with a Postgraduate Diploma in Pharma Management, seeking to apply expertise in regulatory compliance and RIMS implementation to drive organizational success. Skilled in addressing inquiries, managing finances, and engaging with health authorities to uphold regulatory standards and support product registrations. Experienced in CTD dossier submissions for non-regulated markets worldwide.
Experienced Quality Assurance Coordinator with background in developing and implementing quality control systems to ensure consistent product excellence. Strong capacity for managing teams, coordinating audits, preparing reports and maintaining documentation. Proven ability to drive process improvements that increase efficiency and reduce errors. Demonstrated success in improving team performance through innovative training programs and clear communication of objectives.
Overview
19
years of professional experience
Work History
Pharmaris Canada IncVancouver
Regulatory Affairs & Quality Assurance Co-ordinator
05.2025 - 03.2026
Job overview
- Gx-Related Oversight: Manage all Gx activities.
- Lifecycle Management: Oversee the entire product lifecycle.
- Submissions & Notifications: Handle annual or Post NOC notifications and submissions, DNF submission package preparation, DEL applications.
- Batch Releases: Release batches for in-house production and 3PL.
- Labeling Compliance: Ensure that all artworks and labeling meet regulatory requirements.
- Change Management: Lead change control initiatives, including tech transfers.
- Documentation: Maintain product information and master documents.
- Vendor Approvals: Manage approvals for all Gx CMOs and labs (FDF, API sites).
- Customer Service: Address customer complaints and oversee resolution processes.
- Documentation Integration: Streamline documentation with effective cross-reference management.
- GMP Enforcement: Ensure compliance with GMP across operations.
Prime Health LTDVancouver
Regulatory Affairs Executive
02.2024 - 05.2025
Job overview
- Regulatory Documentation & Filing: Compile all required documents in eCTD/CTD format, including labels, quality records, and dossiers, to support product development and registration efforts.
- Compliance Review & Data Validation: Conduct in-depth reviews of submissions, verifying raw data, chromatograms, validation reports, batch records, and artwork to ensure strict adherence to Health Canada and international regulatory standards.
- Regulatory Communication: Draft prompt and precise responses to deficiency notices and resolve dossier-related queries efficiently.
- Product Labeling: Produce regulatory-compliant labeling materials, including Product Monographs and nutrition tables.
- Coordination & International Registration: Collaborate with manufacturing units to secure technical documentation and samples, facilitating the successful registration of health supplements in international markets such as ASEAN, LATAM, the Middle East, and Africa.
GENPACT INDIA PVT. LTDMumbai
Lead Consultant
02.2019 - 09.2023
Job overview
- Regulatory Compliance Gap Analysis: Conducted regulatory compliance gap analysis to identify and rectify compliance issues across multiple markets.
- Offering insightful observations and recommendations for rectifying compliance issues.
- Multi-Market Gap Analysis: Performed gap analyses for markets including Russia, US, EU, Australia, Mexico, Lebanon, Serbia, and Georgia.
- Prepared and organized data for gap analysis in alignment with company guidelines.
- Coordinated with manufacturing plants to ensure raw data requirements were met for analysis.
- Data Enhancement and Migration Support: Assisting in data enrichment and seamless data migration.
- RIMS Implementation and Management: Participated in projects focused on the implementation and administration of Regulatory Information Management Systems (RIMS) such as PRISM, GRACE, and VEEVA.
- Conducted quality checks to ensure the accuracy of enriched data for regulatory compliance.
VHB MEDI SCIENCES LIMITEDMumbai
Regulatory Executive
11.2018 - 01.2019
Job overview
- CTD Dossier Compilation for African Markets: Compiled CTD dossiers for African markets, including Zimbabwe, Kenya, Tanzania, Zambia, Sudan, Ethiopia, Namibia, Uganda, and others.
- Query Submission for non-regulated markets.
- Coordinated with the manufacturing facility to procure necessary technical documentation and samples.
- Verified raw data, chromatograms, validation data, and batch records to maintain data integrity.
RENA EXPORTSMumbai
Regulatory Executive
01.2016 - 08.2018
Job overview
- Dossier Compilation for African Markets: Expertly compiled dossiers tailored for the specific needs of semi-regulated markets in East African and West African countries, including but not limited to Nigeria, Kenya, Tanzania, Zambia, Ivory Coast, Burkina Faso, Benin, and others.
- Efficiently handled dossier queries to ensure successful product registration.
- Collaborated closely with Manufacturing Units to ensure timely documentation and procure necessary samples.
- Orchestrated the collection and arrangement of essential legal documents required for product registration.
- Artwork Compliance Review: Conducted thorough reviews of artwork to ensure alignment with country-specific regulatory requirements.
- Performed meticulous verification of raw data, chromatograms, validation data, and batch manufacturing records to maintain data integrity and regulatory compliance.
Ipca Laboratories LimitedMumbai
Regulatory Coordinator
08.2010 - 12.2015
Job overview
- Registration Submissions Coordination: Orchestrated registration submissions for the CIS, Latin America, West Africa, East Africa, and Southeast Asia regions.
- Query Monitoring and Follow-up: Diligently tracked and followed up on registration queries to ensure prompt resolution.
- Financial Oversight: Oversaw registration-related payments and meticulously managed dossier submission fees.
- R&D Sample Procurement: Procured samples to support Research and Development (R&D) initiatives.
- Resolution of Market Complaints: Effectively addressed and resolved product-related complaints from the market.
- Health Authority Engagement: Coordinated and facilitated plant visits, audits, and inspections by Health Authorities to maintain compliance and regulatory standards.
AJANTA PHARMA LTD.Mumbai
Regulatory Affairs Officer
07.2009 - 08.2010
Job overview
- DCG(I) Dossier Compilation: Skillfully compiled DCG(I) dossiers and took independent charge of DCG(I) requirements.
- Clinical Documentation Coordination: Collaborated effectively with Clinical Research Organizations to acquire necessary clinical documents.
- Successfully oversaw the compilation, dispatch, and sample coordination within the dossier management process.
- Coordinated with the Quality Control department to ensure the accuracy and completeness of documents.
- Rigorously verified raw data to ensure data integrity and compliance.
PELL TECH HEALTHCARE PVT LTD.Mumbai
Regulatory Affairs Officer
08.2007 - 06.2009
Job overview
- Assembled comprehensive dossiers compliant with EU-CTD, Iran CTD, Philippines, Tunisia, Bangladesh, and Pakistan requirements for semi-regulated markets.
- Developed Manufacturing Licenses and Loan Licenses specifically for bulk drug operations.
- Material development for packaging.
- Created essential documentation for quality operations to ensure regulatory compliance.
Education
Institute of Pharmaceutical ManagementMumbai
Postgraduate Diploma from Regulatory Affairs for Drugs (API & Formulation)
Garware Institute of Career Education and DevelopmentMumbai
Postgraduate Diploma from Pharma Management
Mithibai CollegeMumbai
Bachelor of Science from Chemistry
Group Sanofi-AventisMumbai
Industrial Training
University Overview
Completed a 12-week summer internship across various departments focusing on regulatory affairs and related tasks.
Skills
- Regulatory compliance
- Documentation quality
- Product labeling
- Batch release management
- Regulatory communication
- Customer complaint resolution
- Regulatory dossiers
Training
Group Sanofi-Aventis, Mumbai, 05/01/07, 08/01/07, Completed a 12-week summer internship across various departments focusing on regulatory affairs and related tasks.
Work Preference
Job Search Status
Open to workWork Type
Full TimePart TimeContract WorkLocation Preference
On-SiteRemoteHybridSalary Range
$55000/yr - $155000/yrTimeline
Regulatory Affairs & Quality Assurance Co-ordinator
Pharmaris Canada Inc
05.2025 - 03.2026
Regulatory Affairs Executive
Prime Health LTD
02.2024 - 05.2025
Lead Consultant
GENPACT INDIA PVT. LTD
02.2019 - 09.2023
Regulatory Executive
VHB MEDI SCIENCES LIMITED
11.2018 - 01.2019
Regulatory Executive
RENA EXPORTS
01.2016 - 08.2018
Regulatory Coordinator
Ipca Laboratories Limited
08.2010 - 12.2015
Regulatory Affairs Officer
AJANTA PHARMA LTD.
07.2009 - 08.2010
Regulatory Affairs Officer
PELL TECH HEALTHCARE PVT LTD.
08.2007 - 06.2009
Institute of Pharmaceutical Management
Postgraduate Diploma from Regulatory Affairs for Drugs (API & Formulation)
05.2019
Garware Institute of Career Education and Development
Postgraduate Diploma from Pharma Management
06.2007
Mithibai College
Bachelor of Science from Chemistry
03.2006
Group Sanofi-Aventis
Industrial Training
05.2007