Abhijeet Sarkar
Sri Vijaya Puram
Summary
Dynamic Regulatory Affairs Associate with a track record of successful regulatory submissions and cross-functional collaboration. Committed to enhancing regulatory processes and ensuring compliance, ready to drive impactful results in a fast-paced environment.
Overview
3
3
years of professional experience
Work History
Regulatory Affairs Specialist
Bio-Rad laboratories India Pvt.Ltd
Gurugram
03.2025 - Current
- Reviewed regulatory documents for compliance with industry standards for various Divisions.
- Prepared submissions for regulatory approvals (Import License, PACs, Retentions, Queries)
- Coordinated with cross-functional teams to gather necessary information.
- Supported audits by ensuring accurate records and documentation were available.
- Updated in-depth trackers of approvals and submissions.
Regulatory Affairs Associate
Johnson & Johnson Ltd
Gurugram
02.2024 - 02.2025
- Streamlined preparation, review, and submission of essential regulatory documents, encompassing new product registrations, import licenses, and relevant approvals to respective regulatory authorities.
- I assisted in formulating regulatory strategies for the launch and marketing of new products, and I undertook life cycle management of the existing products.
- I managed the regulatory affairs for two key franchises within the India-based business: Ethicon and Biosense Webster (Surgical Products).
Senior Associate
Genpact
Gurugram
05.2023 - 01.2024
- Assisted Global Complaints Handling Management team in efficient identification and resolution of quality issues related to customer complaints.
- Facilitated timely reviews and follow-ups on global customer inquiries, assuring effective handling of complaints
Service Engineer Intern
FUJIFILM India Pvt Ltd
Gurugram
09.2022 - 04.2023
- Installed and configured imaging equipment for customer sites.
- Provided technical support and troubleshooting for medical devices.
- Conducted routine maintenance and repairs on Fujifilm products.
Education
Bachelor of Technology - Biomedical Engineering
DCRUST
Sonipat, Haryana07-2022
Some College (No Degree) - High School
Mahatma Gandhi International School
Sri Vijaya PuramSkills
- Attention to detail
- Problem solving
- Change management
- FDA regulations
- RIMS software
- Proficient with the GCHS interface
Affiliations
- Instruments- Tabla and Harmonium
- Dramatics - Theatre
- Cricket
Timeline
Regulatory Affairs Specialist
Bio-Rad laboratories India Pvt.Ltd
03.2025 - Current
Regulatory Affairs Associate
Johnson & Johnson Ltd
02.2024 - 02.2025
Senior Associate
Genpact
05.2023 - 01.2024
Service Engineer Intern
FUJIFILM India Pvt Ltd
09.2022 - 04.2023
Bachelor of Technology - Biomedical Engineering
DCRUST
Some College (No Degree) - High School
Mahatma Gandhi International School
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