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Rajni Sharma
Regulatory Affairs Professional
Mandi, Himachal Pradesh,Himachal pradesh
Summary
Works well with consulting cross-functional teams on minimizing regulatory risk. Goes above and beyond to manage priorities and problem-solve with quick turn-around expectation.
Overview
13
13
years of professional experience
5
5
years of post-secondary education
Work History
Deputy Manager
Panacea Biotech
New Delhi
07.2024 - Current
- Review of CTD for compliance as per regulatory requirements for submissions in various ROW countries/Domestic for submissions
- Compilation , submission and Publish of eCTD for GCC and ZA region.
- Post approval changes/variations review and submissions to NRA, WHO.
- Ensures timely submission of Query response to various regulatory agencies regarding product registrations
- Collaboration with cross-functional to ensure timely submissions to various regulatory authorities and also to accomplish regulatory goals and achieve full compliance with all products.
- Submission and review of New drug related applications/Clinical trial related applications/CT-10/CT-16.
- Working in Sugam and NSWS portal for submission of application.
- Active Participation in inspections and review of inspection related CAPA.
- Review of documents
- Prioritize project-related tasks to efficiently complete essential tasks.
Assistant Manager-Regulatory Affairs
Panacea biotec Ltd
New Delhi
08.2022 - 07.2024
- Compiled and submitted Registration documents to regulatory agencies in timely and effective manner.
- Collaborated with regulatory agencies to resolve any inquiries or concerns pertaining to product registration and ensures timely submission of Query responses as per requirements.
- Continuous followed up with cross functional departments to ensure timely submission of Dossier/Query responses to different regulatory agencies.
- Ensured that all data produced complies with regulatory requirements.
- Maintained accurate records of all registration related activities.
- Involved in review of various stability protocols, change controls, specifications, risk assessment, study reports etc.
- Preparation and review of CAPA compliances for Audit observations
- Active Participation in Audits.
- Post approval changes submissions
- Variations WHO (PQVAR/Type A/Type N) submissions
- Submission of Clinical trial applications & New Drug approvals and query responses related to same.
- Renewal of Manufacturing licenses/GMP/Form29.
- Operations in SUGAM /NSWS portal.
Assistant Manager-Quality Control
Panacea biotec Ltd
Baddi
08.2017 - 08.2022
- Reviewed data and testing to ensure accuracy and completeness of testing documentation.
- Planned shift schedule and work allocation to team as per production activities.
- Handled CAPA/change controls/ Deviations/investigations.
- Participated in audits and prepared compliance reports
- Prepared and executed study protocols and compiled reports.
- Prepared Procedures (SOP) as per current pharmacopeia's.
- Maintained and reviewed lab usage log books and entry records/Audit Trails
- Prepared monthly trends and annual trends.
- Coordinated with other departments for routine activities.
- Coordinated with outside labs and organization for any sample testing.
- Involved in instrument qualification/calibrations
- IQ,OQ ,PQ ,CSV and software assessment of TOC Analyzer
- Validated and tested different microbiological methods
Executive-Quality Control
Bharat Biotec
Hyderabad
12.2011 - 07.2017
- Prepared Microbiological media
- Culture Maintenance and Growth promotion testing
- Environmental Monitoring
- Microbial Limit Test
- Bacterial Endotoxin testing
- Water testing
- SOPs, study protocols
- Microbiological test method validations
- QMS, CAPA, Change controls and other documentation
- Coordinated with other departments for routine activities.
- Coordinated with outside labs and organization for any sample testing
- Conducted regular audits of existing control systems infrastructure to ensure optimal performance levels were maintained over time
Education
Bachelor of Science - Medical
MLSM College
Sunder Nagar, Himachal Pradesh 04.2006 - 04.2009
Master of Science - Microbiology
Central Research Institute
Kasauli, Himachal Pradesh 05.2009 - 06.2011
Skills
Dedicated
Time management
Multitasking
Team work
Responsible
Dedicated
Efficient
Accomplishments
- Supervised team of 5 staff members.
- Effectively managed all the CT related compliance of vaccines
- Have participated in four successful WHO audits.
- Individually Handled all the registration related queries for hexavalent vaccine.
Timeline
Deputy Manager
Panacea Biotech
07.2024 - Current
Assistant Manager-Regulatory Affairs
Panacea biotec Ltd
08.2022 - 07.2024
Assistant Manager-Quality Control
Panacea biotec Ltd
08.2017 - 08.2022
Executive-Quality Control
Bharat Biotec
12.2011 - 07.2017
Master of Science - Microbiology
Central Research Institute
05.2009 - 06.2011
Bachelor of Science - Medical
MLSM College
04.2006 - 04.2009
Interests
Cooking