Roma Mistry
Vadodara
Summary
Resourceful Regulatory Affairs Specialist known for high productivity and efficient task completion. Possess specialized skills in regulatory compliance, risk assessment, and policy development. Excel in critical thinking, problem-solving, and communication, ensuring seamless navigation through complex regulatory environments.
Overview
14
14
years of professional experience
Work History
Regulatory Affairs Specialist
Mepro Pharmaceuticals Pvt. Ltd.
Vadodara
07.2024 - Current
- Delivered regulatory strategic insights to enhance EU MA filing processes.
- Resolved CMC and regulatory challenges during procedural phases.
- Dossier due diligence activities.
- Review the dossier and prepare a GAP analysis for various client for EU region.
- Review of renewal and variation package for submission of EU market.
- Solving queries raised by regulatory authorities and clients within the given timeframe.
- Review of dossier and documents as per eCTD requirement.
- Co-ordinate with the project teams for timely execution of assigned projects.
- Provide technical information to the business development team
Regulatory Affairs Specialist
Zydus Lifesciences
Ahmedabad
06.2016 - 07.2024
- Compilation and review of product dossiers in compliance with the US market.
- To respond to queries in the form of IR, DRL and CRL.
- Post-approval change management and handling of CNE-0, CBE-30, PAS, and annual reportable submission.
- Determine necessary documentation for submissions and facilitate delivery of approved technical source documents according to project timelines.
- Reviewed and collected various technical documents, including DMF and product development reports.
Executed batch documents and analytical documents to ensure compliance with standards. - Preparation of regulatory transfer docket.
- Proactively keeping up to date with regulatory guidance.
Regulatory Affairs Associate
Sun Pharmaceuticals Ltd.
Vadodara
02.2011 - 06.2016
- Coordinated cross-department efforts to ensure timely document receipt and adherence to deadlines.
- Reviewed CMC documents for drug substances, excipients, and batch records, ensuring compliance.
- Processed sterile document packages, including BET validation and sterility test validations.
- Evaluated qualification protocols for autoclave, DHS, terminal sterilizer, freeze dryer, and Media fill simulation study.
- Prepared sterility packages to meet regulatory standards.
- Addressed queries from regulatory agencies regarding submitted dossiers.
- Managed submission activities for post-approval changes and annual reports.
- Conducted change control reviews to maintain project integrity.
Education
M pharmacy - Quality Assurance
A.R. College of Pharmacy
V.V. Nagar06-2010
Bachelor's - Pharmacy
A.R. College of Pharmacy
V.V. Nagar04-2008
GATE Examination -
IISc
Banglore01.2008
Skills
- Regulatory compliance
- Dossier review
- Gap analysis
- eCTD submission
- Change management
- Project management
- Cross-functional coordination
- Query resolution
- Time management
- Problem solving
- Labeling requirements
- Stakeholder communication
- Data verification
- Validation protocols
- Audits
- Global regulatory compliance
- Impact assessment
- Drug Approval Process
- Team building
Disclaimer
I hereby declare that the above-mentioned information is true and to the best of my knowledge.
Languages
- Gujarati
- Hindi
- English
Mobile Numbers
- +91 9724144917
- +91 9924880205
Affiliations
Attended sessions for Well-being Initiatives, Learning & Development and Leadership Development
Languages
Hindi
First Language
English
Upper Intermediate (B2)
B2
Gujarati
Advanced (C1)
C1
Accomplishments
Recognized a rising star within the organization for demonstrating exceptional growth, adaptability, and performance in a short span.
References
References available upon request.
Timeline
Regulatory Affairs Specialist
Mepro Pharmaceuticals Pvt. Ltd.
07.2024 - Current
Regulatory Affairs Specialist
Zydus Lifesciences
06.2016 - 07.2024
Regulatory Affairs Associate
Sun Pharmaceuticals Ltd.
02.2011 - 06.2016
M pharmacy - Quality Assurance
A.R. College of Pharmacy
Bachelor's - Pharmacy
A.R. College of Pharmacy
GATE Examination -
IISc