Lydia Coddens
Director Regulatory Affairs
Grayslake, Illinois, United States
Professional Overview
Lydia Coddens is an experienced regulatory affairs professional with a strong focus on the pharmaceutical and medical device industries. As the Director of Regulatory Affairs at Abbott, she oversees the development and implementation of regulatory strategies to ensure compliance and support the successful commercialization of innovative products.
Experience Summary
Current Role
As the Director of Regulatory Affairs at Abbott, Lydia is responsible for managing the regulatory approval process for new and existing products. She leads a team of specialists in navigating complex regulatory landscapes, ensuring all submissions meet the required standards and guidelines. Under her leadership, the regulatory affairs department has achieved a 95% first-cycle approval rate, contributing to the company's overall growth and market expansion.
Career Progression
Prior to her current role, Lydia held positions of increasing responsibility within Abbott's Infectious Disease Emerging Markets division. As the Associate Director of Regulatory Operations, she streamlined regulatory processes, reduced approval timelines by 30%, and successfully registered multiple products in high-growth markets. Earlier in her career, she served as a Senior Regulatory Specialist, where she developed a deep understanding of global regulatory requirements and played a crucial role in the launch of several groundbreaking infectious disease diagnostics.
Academic Background
Lydia holds a Master of Science degree in Regulatory Affairs from the University of Illinois at Chicago, where she graduated with distinction. Her specialized knowledge in regulatory science and policy has been instrumental in her career progression and her ability to navigate the evolving regulatory landscape.
Areas of Expertise
- Regulatory affairs strategy and implementation
- Global regulatory compliance and submissions
- Pharmaceutical and medical device product development
- Cross-functional collaboration and stakeholder management
- Technical and scientific writing
- Project management and team leadership
Professional Impact
Lydia's contributions have been recognized by her peers and industry organizations. She has been invited to speak at several industry conferences, sharing her expertise on navigating complex regulatory challenges and driving operational excellence. Additionally, her work has been published in peer-reviewed journals, further solidifying her reputation as a thought leader in the field of regulatory affairs.
Conclusion
With a proven track record of success, Lydia Coddens is a versatile and highly sought-after regulatory affairs professional. Her deep industry knowledge, strategic mindset, and strong leadership skills have positioned her as a valuable asset to Abbott, helping the company maintain its competitive edge in the rapidly evolving pharmaceutical and medical device landscape.
