Professional Summary
Professional Overview
Poonam Kumar is a seasoned executive with over 25 years of experience in the pharmaceutical industry. As the Vice President of Regulatory Affairs at Capstone Development Services Co, LLC, she plays a pivotal role in ensuring the company's products and processes adhere to stringent regulatory requirements both domestically and internationally.
Experience Summary
Current Role
In her current role as Vice President of Regulatory Affairs, Poonam is responsible for overseeing all regulatory compliance activities, including the preparation and submission of regulatory filings, managing interactions with global regulatory agencies, and developing strategies to navigate complex regulatory landscapes. Her expertise in quality assurance and analytical processes has been instrumental in driving the company's product development initiatives and maintaining a strong regulatory standing.
Career Progression
Prior to her current role, Poonam served as the Vice President of Quality and Regulatory at Wockhardt USA / Morton Grove Pharmaceuticals, where she successfully led the implementation of robust quality systems and regulatory compliance programs. She also held the position of Vice President of Regulatory Affairs and Analytical at Wockhardt USA / Morton Grove Pharmaceutical, where she spearheaded the company's analytical and strategic planning efforts.
Earlier in her career, Poonam was the Associate Vice President of Analytical, Strategic Planning, and Project Management at Jubilant Organosys Ltd., and a Senior Research Scientist at Ranbaxy. Throughout her diverse career, Poonam has demonstrated a proven track record of driving operational excellence, fostering cross-functional collaboration, and delivering tangible results that have positively impacted her employers' competitive positioning and market share.
Academic Background
Poonam holds a strong academic background, having earned her education in the field of pharmaceutical sciences.
Areas of Expertise
Poonam's areas of expertise include:
- Regulatory affairs and compliance
- Quality assurance and analytical processes
- Strategic planning and project management
- Cross-functional team leadership and collaboration
- Navigating complex regulatory landscapes
Professional Impact
Poonam's strategic leadership and technical expertise have been instrumental in driving her employers' success. She has been recognized for her ability to develop and implement effective regulatory strategies, optimize quality systems, and ensure the timely and successful commercialization of pharmaceutical products.
Conclusion
With her extensive experience, proven track record of success, and deep industry knowledge, Poonam is well-positioned to continue driving Capstone Development Services Co, LLC's regulatory and quality initiatives, contributing to the company's overall growth and market dominance.
