MITHUN KUMAR D
Chennai
Summary
Regulatory Operations leader with nearly 8 years of expertise in submissions management, publishing, and inspection readiness within pharmaceutical industry. Recognized for streamlining processes, fostering team development, and accelerating dossier delivery—achieved 25% reduction in submission cycle times through SOP optimization and automation.
Overview
12
12
years of professional experience
Work History
Senior Team Lead - Regulatory Operations
Pfizer
Chennai
06.2023 - Current
- Led regulatory operations for submissions, document management, and compliance to fulfill regional requirements.
- Optimized strategies, achieving 25% improvement in submission timelines and enhancing team efficiency.
- Implemented lean processes and templates to strengthen SOP adherence and ensure inspection readiness.
- Provided training on submission standards, document management, and publishing best practices.
- Developed VBA-enabled Excel automation for tracking submission and renewal timelines for GMP clearance.
- Designed Power BI dashboards for real-time KPI metrics tracking and data-driven decision-making.
Team Lead - Regulatory Operations
Pfizer
10.2020 - 05.2023
- Developed regulatory strategies for new registrations and post-approval changes to ensure compliance with evolving requirements.
- Authored and maintained SOPs and controlled templates for regulatory operations.
- Monitored regulatory updates and communicated changes to stakeholders, aligning cross-functional deliverables.
- Managed vendor relationships to secure timely and accurate submissions across manufacturing, translations, and legalizations.
Senior Executive
Pfizer
11.2018 - 09.2022
- Prepared submissions for regulatory agencies, including NDA and postmarketing authorization applications.
- Coordinated cross-functional teams to gather and review documentation for regulatory compliance.
- Developed standardized templates and procedures to streamline regulatory submission processes.
- Conducted regulatory assessments and gap analyses to identify issues and formulate mitigation strategies.
Executive
Pfizer
04.2017 - 10.2018
Documentation Officer - Quality Control
Suntara Cosmetics (SCION International)
04.2016 - 04.2017
Research and Development Chemist
Balmer Lawrie
12.2014 - 03.2016
Internship
Oil and Natural Gas Corporation Ltd (ONGC)
12.2013 - 03.2014
Education
MSc - Chemistry - Polymer
University of Madras
ChennaiBSc - Chemistry
Loyola College
ChennaiSkills
- Power BI and SAP BI
- Regulatory submissions
- MS Visio
- Vendor management
- Risk assessment
- People and stakeholder management
- Team leadership and development
- Excel VBA
- Project management
- Process optimization
- Decision-making and critical thinking
- Data analysis and metrics
- Regulatory compliance strategies
- Submission strategy
Accomplishments
Comirnaty & Paxlovid Registration – APAC: Supported the successful regulatory approval and market entry of COVID-19 vaccines across the Asia-Pacific, ensuring timely submissions and compliance with local requirements.
Timeline
Senior Team Lead - Regulatory Operations
Pfizer
06.2023 - Current
Team Lead - Regulatory Operations
Pfizer
10.2020 - 05.2023
Senior Executive
Pfizer
11.2018 - 09.2022
Executive
Pfizer
04.2017 - 10.2018
Documentation Officer - Quality Control
Suntara Cosmetics (SCION International)
04.2016 - 04.2017
Research and Development Chemist
Balmer Lawrie
12.2014 - 03.2016
Internship
Oil and Natural Gas Corporation Ltd (ONGC)
12.2013 - 03.2014
MSc - Chemistry - Polymer
University of Madras
BSc - Chemistry
Loyola College