Gabriella K.

Associate Director, Regulatory Affairs, Product Care Lead

Professional Overview

Gabriella K. is an accomplished regulatory affairs professional with extensive experience in the pharmaceutical industry. As the Associate Director of Regulatory Affairs and Product Care Lead at Johnson & Johnson, she leverages her deep expertise to oversee critical regulatory processes and ensure the successful development and commercialization of pharmaceutical products.

Experience Summary

Current Role

In her current role at Johnson & Johnson, Gabriella is responsible for leading the regulatory affairs team, managing product submissions, and overseeing the product care lifecycle. She plays a pivotal role in navigating complex regulatory landscapes, ensuring compliance with industry standards, and driving the timely and effective approval of new pharmaceuticals.

Career Progression

Prior to her current position, Gabriella held several progressive roles at Bristol Myers Squibb, where she demonstrated her ability to excel in submission management. As a Senior Submission Manager, she was instrumental in streamlining processes, improving submission quality, and contributing to the successful launch of multiple pharmaceutical products.

Academic Background

Gabriella holds a Bachelor of Science degree in Pharmaceutical Sciences from a leading university, where she graduated with distinction and showcased her academic prowess.

Areas of Expertise

• Regulatory affairs and compliance

• Pharmaceutical product development and commercialization

• Submission management and strategic planning

• Cross-functional collaboration and stakeholder engagement

• Team leadership and project management

Professional Impact

Throughout her career, Gabriella has made significant contributions to the pharmaceutical industry. She has led the successful submission and approval of several high-profile drug products, resulting in improved patient access to innovative therapies. Gabriella's expertise and strategic thinking have been instrumental in navigating complex regulatory landscapes and driving product success.

Conclusion

With her proven track record of excellence in regulatory affairs and product care, Gabriella is poised to continue making a meaningful impact in the pharmaceutical industry. Her deep expertise, collaborative approach, and commitment to driving positive outcomes make her a valuable asset to the organizations she serves.