BHUWAN SINGLA
Gurugram
Summary
Regulatory and Quality Assurance leader with 15+ years in the Medical Device industry. Proven expertise in Regulatory Affairs and Quality System Compliance, consistently leading teams to achieve organizational goals. Skilled in navigating complex regulatory environments, with a strong focus on continuous improvement and mentorship.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Senior Manager, Regulatory Affairs
Johnson & Johnson
Gurugram
11.2017 - Current
- Company Overview: Leading medical device company
- Successfully managed a team of 9 (6+3*) *Assigned for BIS Project
- Regulatory professionals drive collaboration and performance to achieve organizational goals.
- Oversaw the management of over 90 licenses in India for Orthopaedics Business and 120+ licenses across neighboring markets for all Business Units, ensuring compliance with local regulations and standards.
- Lead BIS Standards Management, including conducting gap assessments, shaping new standards, and actively participating in relevant MHDs to enhance regulatory frameworks.
- Engaged with Government Affairs, Commercial, Supply Chain, and Legal teams on regulatory matters, fostering strong partnerships to navigate complex regulatory environments (BIS, NPPA, Legal Metrology, etc.).
- Conducted comprehensive regulatory intelligence and standards management, ensuring the organization remains compliant and proactive in response to regulatory changes.
- Committed to people development through mentoring and training initiatives, enhancing team capabilities, and promoting a culture of continuous learning and improvement.
Regulatory Affairs Manager
Johnson & Johnson
Gurgaon
07.2021 - 03.2024
Manager Quality
Johnson & Johnson
Mumbai
11.2017 - 06.2021
Assistant Manager, Quality
Baxter Healthcare Limited
Gurgaon
05.2014 - 10.2017
Executive Validation
Ranbaxy
Baddi
07.2011 - 04.2014
Project Trainee
Nectar Lifesciences
Baddi
06.2010 - 11.2010
Trainee Officer - Campus Placement
Ranbaxy
Mohali
08.2009 - 04.2010
Education
Masters of Pharmacy - Pharmaceutics
Punjab Technical University
01.2010
Skills
- Regulatory affairs
- People management
- Quality system compliance
- Supply chain processes
- Budget oversight
- Cross-functional collaboration
- NPI launches
- Market intelligence
Accomplishments
- Digital Products Registration
- Chief Author, Pathway for Harmonizing Medical Device Registration in Sri Lanka
- Achieved 10+ NPI launches in 12 months
Certification
- ISO 13485:2016 Certified Lead Auditor
Languages
Hindi
First Language
English
Advanced (C1)
C1
Punjabi
Proficient (C2)
C2
References
References available upon request.
Timeline
Regulatory Affairs Manager
Johnson & Johnson
07.2021 - 03.2024
Senior Manager, Regulatory Affairs
Johnson & Johnson
11.2017 - Current
Manager Quality
Johnson & Johnson
11.2017 - 06.2021
Assistant Manager, Quality
Baxter Healthcare Limited
05.2014 - 10.2017
Executive Validation
Ranbaxy
07.2011 - 04.2014
Project Trainee
Nectar Lifesciences
06.2010 - 11.2010
Trainee Officer - Campus Placement
Ranbaxy
08.2009 - 04.2010
Masters of Pharmacy - Pharmaceutics
Punjab Technical University
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