Open To Work
Rajkumar Kachhu
Telangana
Work Preference
Summary
Experienced Plant Regulatory Affairs Professional with over 10 years in pharmaceutical manufacturing and regulatory compliance. Expertise in preparing and submitting regulatory dossiers for diverse global markets, including CTD/eCTD documentation and lifecycle management. Proficient in reviewing GMP documents and collaborating across departments to uphold cGMP and global regulatory standards, facilitating inspections and product registrations.
Overview
3
3
Languages
12
12
years of professional experience
Work History
Regulatory Affairs Manager
Digital Vision
himachal pradesh
11.2024 - 12.2025
- Coordinated regulatory documentation and compliance across ASEAN, West African, LATAM, and ROW markets to support timely product registrations.
- Reviewed artwork and quality documents (BMR, BPR, PV, hold time, stability, specifications) for adherence to regulatory standards, ensuring compliance prior to submission.
- Oversaw quality management system to implement change controls for supplements and variations, enhancing regulatory submission accuracy.
- Managed international regulatory submissions and lifecycle activities.
- Arrangements of Samples to the Local Agents of Export Countries for Product Registration.
- Co-Ordination with other Cross-Functional Departments Like QA, QC, Production, R&D, Marketing, Purchase, For Documents, Query Response.
Regulatory Affairs Officer
Sri Krishna Pharmaceuticals Ltd
Hyderabad
04.2024 - 10.2024
- Coordinated preparation, review, compilation, and submission of regulatory dossiers for ASEAN countries, ensuring compliance with local regulations.
- Managed international regulatory submissions and lifecycle activities.
- Reviewed artwork and quality documents (BMR, BPR, PV, hold time, stability, specifications) for compliance with regulatory standards.
- Facilitated collaboration with cross-functional departments (QA, QC, production, R&D, marketing, purchase) to address regulatory document queries.
Regulatory Affairs Officer
Marksans Pharma Ltd.
Goa
01.2022 - 03.2024
- Coordinated regulatory documentation and compliance for US market preparation, reviewing and compiling regulatory dossiers for submission to US and UK authorities.
- Managed international regulatory submissions and lifecycle activities.
- Annual Reports, PAS, CBE-30, CBE-0 Supplement/Variations Preparation.
- Reviewed artwork and quality documents for compliance with regulatory standards, ensuring adherence to specifications and stability requirements.
- Oversaw change control processes in quality management system for submissions. -Change Controls For Supplements/ Variations Submission.
- Coordinated sample arrangements for local agents for product registration. to the Local Agents of Export Countries for Product Registration.
- Coordinated with cross-functional departments (QA, QC, production, R&D, marketing, purchasing) for document preparation and query responses.
Regulatory Affairs Associate
DD Reg Pharma Pvt. Ltd.
gurgaon
01.2019 - 10.2021
- Managed regulatory documentation and compliance processes across ASEAN, West African, LATAM, and ROW markets to ensure adherence to regional regulations.
- Managed international regulatory submissions and lifecycle activities.
- Oversaw the implementation of Change Controls in the QMS for regulatory compliance. -Change Controls For Supplements/ Variations Submission.
- Reviewed and approved artwork for compliance with regulatory standards. and Review of Quality Documents (BMR, BPR, PV, Hold time, stability, Specifications)
- Coordinated with cross-functional departments (QA, QC, Production, R&D, Marketing, Purchase) to ensure accurate document preparation and timely query responses.
- Organized and dispatched product samples to agents in export countries for registration. to the Local Agents of Export Countries for Product Registration.
Regulatory Affairs Junior Executive
SP Accure Labs Pvt. Ltd.
Hyderabad
01.2017 - 01.2019
- Prepared, reviewed, compiled, and submitted regulatory dossiers for ASEAN countries to ensure compliance and timely approvals.
- Managed international regulatory submissions and lifecycle activities.
- Reviewed artwork for compliance with regulatory standards and branding guidelines. Review of Quality Documents (BMR, BPR, PV, Hold time, stability, Specifications)
- Facilitated communication and document exchange among departments to support project goals. with other Cross-Functional Departments Like QA, QC, Production, R&D, Marketing, Purchase, For Documents.
- Arrangements of Samples to the Local Agents of Export Countries for Product Registration.
QA – Regulatory Support Officer
Hetero Labs Ltd.
Hyderabad
05.2014 - 04.2017
- Supported regulatory dossier filing (US, EU, ROW) through cross-functional collaboration.
- Provided timely responses to inquiries regarding regulatory compliance., Maintained organized archival records of licenses, ensuring efficient retrieval., Assisted in managing and organizing agreements documentation for review..
- Artwork Review and Review of Quality Documents (BMR, BPR, PV, Hold time, stability, Specifications)
- Arrangements of Samples to the Local Agents of Export Countries for Product Registration.
- Coordinated document preparation with QA, QC, production, R&D, marketing, and purchasing departments.
Education
Master of Pharmacy - Pharma Analysis and Quality Assurance
JNTU Hyderabad
Hyderabad, Telangana01-2014
Bachelor of Pharmacy -
Kakatiya University
Warangal, Telangana04-2010
Skills
- Regulatory submissions
- Regulatory compliance
- Regulatory documentation review
- Dossier preparation
- Regulatory strategy
- Lifecycle oversight
- Change control management
- Compliance documentation
- Quality assurance oversight
- Artwork review
- Artwork compliance standards
- Health authority responses
- Regulatory quality assurance
- Cross-functional collaboration
- Coordination across functions
- Project management
- Regulatory insights
Roles And Responsibilities
- Preparation and compilation of CTD dossiers.
- US, ASEAN, LATAM, and MENA submissions.
- Variation and supplement submissions.
- Review of BMR, BPR, specifications, stability data, and quality documents.
- Regulatory query responses.
- Artwork review.
- Coordination with QA, QC, Production, R&D, Purchasing, and Marketing.
- Sample coordination for product registrations.
- Regulatory document management and archival.
Languages
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Telugu
Proficient (C2)
C2
Timeline
Regulatory Affairs Manager
Digital Vision
11.2024 - 12.2025
Regulatory Affairs Officer
Sri Krishna Pharmaceuticals Ltd
04.2024 - 10.2024
Regulatory Affairs Officer
Marksans Pharma Ltd.
01.2022 - 03.2024
Regulatory Affairs Associate
DD Reg Pharma Pvt. Ltd.
01.2019 - 10.2021
Regulatory Affairs Junior Executive
SP Accure Labs Pvt. Ltd.
01.2017 - 01.2019
QA – Regulatory Support Officer
Hetero Labs Ltd.
05.2014 - 04.2017
Master of Pharmacy - Pharma Analysis and Quality Assurance
JNTU Hyderabad
Bachelor of Pharmacy -
Kakatiya University