Gabriella K.

About Gabriella K.

Dedicated, accountable, and collaborative, professional with 19-years pharmaceutical experience with proven success in managing all aspects of regulatory operations obtaining necessary health authority approvals to help patients prevail over serious diseases.

Experience

1. Associate Director, Regulatory Affairs, Product Care Lead

   Johnson & Johnson

   Dec 2024 — Present · NJ, US

   As Associate Director, Submissions Management, I lead and coordinate global submission activities, managing the submission, approval, and lifecycle maintenance of products. I oversee the creation and management of complex Dossier Plans and Submission Packages, ensuring they align with regulatory strategies and comply with health agency regulations and standards. I collaborate closely with cross-functional teams, including regulatory therapeutic areas, stakeholders, and department representatives, to ensure the accuracy and completeness of submissions. I leverage my expertise to shape strategic direction and provide guidance to cross-functional project teams, ensuring alignment and successful outcomes. In addition to managing submission activities, I work independently to drive results, while also driving process improvements and enhancing departmental practices to optimize submission efficiency.

Education

• Rutgers University

  BS, Labor and Employee Relations

• Mercer County Community College

  Liberal Arts and Sciences/Liberal Studies

• Drexel University

  Clinical Research Organization and Management