Prashant Kumar
Hyderabad
Summary
Dedicated and detail-oriented Regulatory Affairs professional with 12.4 years of experience in Pharmaceutical, Medical Device and Chemical Industry. Proven track record of offering project management, advocacy, strategic planning, and problem-solving acumen. Assist global GTAL in accomplishing demanding targets by encouraging the staff and coordinating resources.
Regulatory affairs professional with comprehensive experience in navigating complex regulatory landscapes and ensuring compliance. Strong focus on team collaboration and achieving results, with adaptable approach to changing needs. Skilled in regulatory strategy, risk assessment, and policy development. Valued for reliability, analytical mindset, and effective communication in high-stakes environments.
Overview
13
13
years of professional experience
6
6
Certifications
Work History
Senior Global Program Regulatory Manager
Novartis
08.2024 - Current
- Spearheaded execution of extensive global regulatory program for diverse products and therapeutic areas.
- Assist Global Therapeutic Area Leads in strategizing and implementing submission plans for initiatives including Annual Reports, Amendments, Variations, Query Responses, and Pediatric Investigation Plans.
- Assist product advocacy and negotiation efforts with health agencies.
- Collaborated with global team to oversee product registration and life cycle management.
- Led project teams by ensuring compliance with regulatory requirements throughout product development stages.
- Played a key role in strategic planning meetings, providing expert regulatory advice to support business objectives.
- Enhanced regulatory compliance by developing and implementing effective policies and procedures.
- Negotiated favorable terms on consent agreements, minimizing company liability while maintaining good standing with regulators.
Advanced PSRA Representative
Eastman Chemical Company
10.2020 - 08.2024
- Assisted the business unit in managing resources and people, enhancing their ability to provide regulatory and advocacy support globally.
- Spearheaded special projects and resolved complex problems that impacted management and business direction.
- Complied with various regional and global regulatory frameworks including India, USFDA, EU REACH, Health Canada EMA, NMPA, SFDA.
- Communicated with regulatory agencies.
- Updating regulatory data/information.
- Ensured compliance with internal audit/QMS requirements by developing and implementing RA SOP.
- Manage the progress of work and training materials related to authoring and other core tasks.
- Contributed to assessment of suitable classifications for new products and medical devices.
- Managed the filing and guidance of stakeholders for product registrations in various regions.
- Collaborated with clients and customers to acquire, communicate, and distribute updated information about products and services.
- Handled customer complaints quickly and professionally to restore customer confidence and prevent loss of business.
Assistant Manager – RA & QA
Lundbeck
01.2015 - 10.2020
- Liaised with authorities to facilitate product licensing for new pharmaceuticals and medical devices alongside renewal of existing licenses.
- Optimized documentation process and elevated efficiency in managing product and international clinical trial registrations.
- Managing CMO, Production planning, Performing quality check on regulatory documents.
- Collaborate with site for up-gradation, qualification, validation, and start-up
- Evaluated risks and benefits to make informed quality and regulatory decisions.
- Led Health Authority interactions, negotiations, and transactions by establishing targets, managing briefings, synchronizing tasks, and formulating strategies.
- Led Change Control, CAPA processes, and managed deviations, product quality complaints, QMS.
- Completed on-time and cost-effective project management for senior leadership, successfully resolving complex financial issues.
- Proactively identified and solved complex strategy problems that impact business direction.
- Providing RA intelligence/strategy to global project lead/Managers.
- Educated stakeholders on product safety protocols, new drug and medical device approval processes, and revisions to labeling and promotional materials.
- Supervised day-to-day operations to meet performance, quality and service expectations.
Regulatory Affairs Associate III
Novo Nordisk
03.2013 - 12.2014
- Assessed required documentation for international medical device submissions and facilitated timely delivery of approved technical source documents.
- Assess content, quality, and timeliness issues within source documents, identifying potential factors affecting submission quality or timelines.
- Ensured accurate regulatory publishing, verification, and dispatch operations while managing logistics and submission dossiers for marketing authorization and life cycle management.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Performed and documented quality control checks to maintain compliance with company initiatives.
Clinical Supply Trainee
Novartis
07.2012 - 12.2012
- Handled and resolved inquiries concerning label text, content, and regulatory requirements for label creation as primary point of contact in Global Drug Supply Management.
- Labeling for bulk supply, resupply, and order processing.
- Archiving all relevant documents and communications in GMP-compliant manner.
- Collaborated with affiliate RA heads to guarantee timely supply of IMP aligned with country-specific requirements.
- Learned new materials, processes, and programs quickly.
- Attended training courses to build understanding of processes, techniques, and industry.
Education
Certificate Program - Project Management: Theory & Practice
Indian Institute of Technology
03.2024
Master of Pharmacy - Pharmaceutical Regulatory Affairs
JSS College of Pharmacy
02.2012
Bachelor of Pharmacy - undefined
Dayananda Sagar College of Pharmacy
11.2009
Skills
- Pharmaceuticals
- Medical devices
- REACH, Medical Grade Polymers
- MS Project, SAP
- CDSCO, IPC, NPPA
- NDA, eCTD
- CMC, DMF API, Excipient
- LCM activities, Labelling
- 510K, EU MDR, PMA, ISO 13485, ISO 10993
- GMP, QMS, Audits, CAPA
- Contract Manufacturing
- Outsourcing, Import License
Auditing expertise
Regulatory research
Regulatory policies
Regulatory submissions
Global regulatory compliance
International regulations
ISO standards
Document management
Risk management
Product lifecycle management
Audits
Regulatory strategy development
Certification
NPTEL - Dental Biomaterial's – 06/2024
Accomplishments
- NRV launch
- Advocacy & Product Registration in US, Europe, Canada, India, China, South Korea, Taiwan, Japan
Publications
Physicochemical characterization and toxicological evaluation of plant based anionic polymers and their nanoparticulated system for ocular delivery, Deepa Pathak, Prashant Kumar, Gowthamarajan Kuppusamy, Ankur Gupta, Bhagyashree Kamble, Ashish Wadhwani, Journal of Nanotoxicology Nanotoxicology, 12/2014, 8, 8, 843-855, 5.8
Timeline
Senior Global Program Regulatory Manager
Novartis
08.2024 - Current
Advanced PSRA Representative
Eastman Chemical Company
10.2020 - 08.2024
Assistant Manager – RA & QA
Lundbeck
01.2015 - 10.2020
Regulatory Affairs Associate III
Novo Nordisk
03.2013 - 12.2014
Clinical Supply Trainee
Novartis
07.2012 - 12.2012
Master of Pharmacy - Pharmaceutical Regulatory Affairs
JSS College of Pharmacy
Bachelor of Pharmacy - undefined
Dayananda Sagar College of Pharmacy
Certificate Program - Project Management: Theory & Practice
Indian Institute of Technology
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