Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Certification
Languages
References
Timeline
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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
BHUWAN SINGLA