Akash Rajbhar
Summary
Regulatory Publishing professional with 2.5 year of experience in end-to-end submission publishing for global markets including US, EU, Canada and APAC regions. Skilled in eCTD, NeeS and paper submission formats with hand-on experience in tool such as Lorenze Docubridge and ORION. Proficient in performing publishing, assembly, dispatch of dossier and archival into repository.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Associate
TATA Consultancy Services
05.2023 - Current
- Supervising submission, which include a publishing request from the initial phase to dispatch and archivel into repository
- Assembly and validating eCTD dossier for US market and Submission publishing of regulatory application with electronic submission for different market such as GCC, US, EU and Canada
- Publishing submission including ANDA, IND, BLA, DMF and NDA applications and submitting them to CDER and CBER through ESG portal.
- Efficiently managing regulatory documentation to meet electronic publishing standards, health authority guidelines and adhering to standard operating procedure (SOPs)
- Familiar with all modules (modules 1 to 5) and ICH guidelines(Quality, Safety, Efficiency, Multidisciplinary)
- Faced TCS-CQA audit, iOMS, Client audit
- Conducted regulatory compliance reviews to ensure adherence with industry standards and guidelines.
- Collaborated with cross-functional teams to prepare and submit regulatory documentation for product approvals.
- Reviewed labeling and promotional materials for compliance with regulatory requirements and corporate policies.
- Assisted in maintaining electronic filing systems for regulatory submissions and correspondence, ensuring accuracy and accessibility.
- Recommended improvements to processes.
- Prioritized project-related tasks to efficiently complete essential tasks.
Education
Pharmacy
Rajiv Gandhi University of Health Science
Bengaluru, India11-2022
Skills
- Veeva Vault
- Lorenz Docubrigge
- Liquent insight or Orion
- Lorenz eValidator, Nees checker, insight validator, EURS validator
- REDS(D2)
- Adobe ISI toolbox (bookmarking, hyperlinking)
- MS Office
- Good manufacturing practices
- ICH guidelines
Certification
Drug Regulatory Affairs
Timeline
Regulatory Affairs Associate
TATA Consultancy Services
05.2023 - Current
Pharmacy
Rajiv Gandhi University of Health Science
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