JOMEL RAJU
Ridgefield,NJ
Summary
Highly self-motivated, creative, and persistent Regulatory Affairs Professional with 2+ years of experience filing high quality regulatory submissions, interacting with regulatory agencies, and project teams, concerning submissions, and reviewing analytical data to ensure that all requirements are met in time.
Overview
2
2
years of professional experience
Work History
QA Associate
Appco Pharma
Piscataway, NJ
08.2023 - Current
- Experience in all the key aspects of Quality Assurance.
- Gained experience in widely used associated systems of Quality Management Systems (QMS) of Deviations (Incident), Investigations, CAPA, Root cause analysis, change controls, Risk assessments.
- Performing of Acceptable Quality Limits (AQL), Blending, compression, Encapsulation, coating of Tablets and capsules.
- Sound knowledge of 21 CFR compliance software like MODA (Environmental monitoring and Facility Pro), TrackWise. Caliber QMS and Master Control.
- Performing of Acceptable Quality Limits (AQL), Blending, compression, Encapsulation, coating of Tablets and capsules
- Responsible for audit and compliance
Regulatory Affairs Specialist
Biocon
08.2021 - 08.2022
- Reviewed scientific literature and supported clinical pharmacology writing for IND submission.
- Liaised with contacts such as pharmaceutical companies.
- Developed user guidelines, update SOPs and Work Instructions for Irvine-based processes and systems.
- Populated templates for protocols, reports, and supporting documents for regulatory submission.
- Excellent skills in documents quality control, formatting, and publishing in-house reports.
- E-submission readiness checks on CRO reports.
Education
Master of Science - DRUG REGULATORY AFFAIRS
Long Island University
Brooklyn, NY04-2024
Bachelor of Science - PHARM.D
KUHS
INDIA06-2021
Skills
- Test Reporting
- User Acceptance Testing
- Quality Assurance Processes
- Regulatory Compliance
- Performance Monitoring
- Sampling
- Finished Product Inspection
- Documentation and Reporting
- Quality Assurance
Accomplishments
- Member of American Association of Pharmaceutical Science
- Member of Kerala Pharmacy Council
- Member Infectious Diseases Society of America
Computer Systems
- Ms Suite
- Medsef
- Pharma Expo
- clinical Research IO
- SPSS
Training and Certifications
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA)
- Good Clinical Practice (U.S. FDA Focus)
- Introduction of FDA HUMAN DRUG REVIEW AND APPROVAL BASICS
References
References available upon request.
Timeline
QA Associate
Appco Pharma
08.2023 - Current
Regulatory Affairs Specialist
Biocon
08.2021 - 08.2022
Master of Science - DRUG REGULATORY AFFAIRS
Long Island University
Bachelor of Science - PHARM.D
KUHS
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