Dadaso Karande
Pune
Summary
Regulatory Affairs professional with 2.5 years of experience in CRO and pharmaceutical submissions. Skilled in CTD/eCTD dossier preparation, global compliance (EMEA, APAC, NA, LATAM) and regulatory documentation. Hands-on expertise in Raw material specifications, packaging documentation, and regulatory databases. Recognized for process excellence, accuracy, and cross- functional collaboration. Completed a Certified Regulatory Affairs course to strengthen knowledge of global regulations.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Associate – Regulatory Affairs
Clinchoice Private Ltd.
Banglore
02.2026 - Current
- Project: GTR (Global Request Tracker) Project – Kenvue (EMEA, APAC, North America, LATAM).
- Create and/or revise Raw Material specifications using client RMQ and Concerto system.
- Work across regions (EMEA, APAC, North America, LATAM) for specification creation, remediation, routing, data mining, and obsolescence activity.
- Create and manage Global Change Controls (GCCs) for revisions to raw material and packaging specifications.
- Coordinate with Procurement, Analytical, Technical Assurance, external manufacturers, suppliers, and distributors for change impact assessment and implementation.
- Supporting preparation and submission of regulatory dossiers in compliance with ICH and CTD guidelines.
- Collaborating with cross-functional teams to ensure timely data collection and documentation.
- Contribute to GTR Global Request Tracker Project by updating, reviewing, and routing specifications for Raw Material.
- Ensure compliance of operations with global regulatory requirements.
- Deliver high standards of customer service by maintaining accurate and timely regulatory documentation.
- Familiar with CAPA, QMS, Change Controls, Deviations, and SOP preparation/review.
Regulatory Operations Assistant I
Fortrea (formerly Labcorp Drug Development)
Pune
07.2024 - 12.2025
- Project: Lorax and GSP/ Global Sustainability Projects – Kenvue (EMEA, APAC, North America, LATAM) Johnson and Johnson.
- Create and/or revise Finished Good, Decorative Components, and Packaging Component specifications using client TRU system.
- Work across regions (EMEA, APAC, North America, LATAM) for specification creation, remediation, routing, data mining, and obsolescence activity.
- Create and manage Global Change Controls (GCCs) for revisions to raw material and packaging specifications.
- Coordinate with Procurement, Analytical, Technical Assurance, external manufacturers, suppliers, and distributors for change impact assessment and implementation.
- Supporting preparation and submission of regulatory dossiers in compliance with ICH and CTD guidelines.
- Collaborating with cross-functional teams to ensure timely data collection and documentation.
- Contribute to Lorax and GSP Global Sustainability Projects by updating, reviewing, and routing specifications for packaging materials.
- Ensure compliance of operations with global regulatory requirements.
- Deliver high standards of customer service by maintaining accurate and timely regulatory documentation.
- Apply knowledge of IPQC techniques (UV, IR, Potentiometry, Water content, sampling).
- Familiar with CAPA, QMS, Change Controls, Deviations, and SOP preparation/review.
- Basic understanding of Medical Device Regulatory Submissions (510(k), ISO 13485, MDR, Pre-market and Post-market submissions).
Emergency medical assistance
Career Break
Pune
04.2023 - 04.2024
- Focused on health, skill development, and certification courses.
Junior Regulatory Affairs Specialist
Labcorp Drug Development
Pune
03.2022 - 03.2023
- Project: RMQ: Zarbee’s – Kenvue (EMEA, APAC, North America, LATAM) Johnson and Johnson.
- Ensured compliance with NA Nutraceutical Regulations, EU REACH, and APAC requirements.
- Prepared, compiled, and reviewed regulatory/quality documents for global submissions.
- Managed raw material questionnaires (RMQ, Tru System) and packaging specifications.
- Maintained regulatory databases (AWS, SharePoint, Live Tracker)
- Collaborated with suppliers/clients to obtain data, approvals, and regulatory updates.
- Awarded Process Excellence Award (Jan 2023) for improving submission accuracy and timelines.
Education
M.Pharm - Pharmaceutics
Shivaji University Kolhapur
Kolhapur06.2021
B.Pharm -
Mumbai University
Mumbai06.2019
D. Pharm -
Mumbai University
Mumbai05.2017
Skills
Skills Associated With Job:
- Raw Material Data Management
- CTD eCTD
- Regulatory Publishing
- Regulatory Submissions
- Regulatory Requirements
- Regulatory Approvals
- Regulatory Archiving
- Regulatory Compliance
- Lifecycle Management
- Troubleshooting
- QMS
Core Skills:
- Regulatory Writing
- Data Review
- Client & Supplier Coordination
- Quality Documentation
Global Regulatory Compliance:
- APAC
- EMEA
- NA
- LATAM
Technical Skills / Skilled with Clients various regulatory software's:
- RMQ
- Tru ENOVIA
- Concerto
- Prisma
- ProductVue
- Veeva Vaults
- ChemID
- Adobe Acrobat
Database Management:
- AWS
- SharePoint
- Live Tracker
Professional Skills:
- Excellent verbal and written communication skills
- Analytical observation skill
- Flexible and adaptable to fulfil business priorities
- Excellent attention to details
Certification
• Certified Regulatory Affairs Course, Global Institute of Regulatory Affairs, Pune, 6 Months, 2024
• Certificate in CTD & eCTD Preparation and Submission, Udemy, 2024
• Certified Bridge Course in Regulatory Affairs, BVCP, Kolhapur, 2024
• Certificate in CTD & eCTD Preparation and Submission, Udemy, 2024
• Certified Bridge Course in Regulatory Affairs, BVCP, Kolhapur, 2024
Accomplishments
Process Excellence Award, Awarded Process Excellence Award at Labcorp for improving efficiency in regulatory submissions.
Extracurricular Activities
Volunteer, The Art of Living NGO, 12+ years of active service in community development, training, and leadership activities
Personal Information
- Total Experience: 2 years and 6 months
- Date of Birth: 04/03/1997
- Gender: Male
- Marital Status: Unmarried
Affiliations
Won the Inter-Office Cricket Tournament in 2025 as Captain.
Languages
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Marathi
Native
Native
Timeline
Associate – Regulatory Affairs
Clinchoice Private Ltd.
02.2026 - Current
Regulatory Operations Assistant I
Fortrea (formerly Labcorp Drug Development)
07.2024 - 12.2025
Emergency medical assistance
Career Break
04.2023 - 04.2024
Junior Regulatory Affairs Specialist
Labcorp Drug Development
03.2022 - 03.2023
M.Pharm - Pharmaceutics
Shivaji University Kolhapur
B.Pharm -
Mumbai University
D. Pharm -
Mumbai University