Mary S.

Regulatory Affairs Associate @ Network Partners Group

About

I have a solid academic background and extensive professional experience in regulatory sciences. . I have learned of all the valuable contributions that are crucial in ensuring a company's adherence to regulatory standards. My educational journey begins with a Bachelor's degree in Biological Sciences from Florida State University with a minor in Chemistry, providing me with a comprehensive foundation of biological and chemical processes.My completeion of a Masters' degree in Regulatory Science from Johns Hopkins University showcases my commitment to excellence in regulatory compliance. I have ultimate aspiration to collaborate with regulatory bodies and contribute to the safe and effective delivery of healthcare products for the public.

Country

City

United States

Industry

Biotechnology

Skill

Regulatory Affairs, Communication, Organization Skills, Medical Devices, Quality Assurance, cGMP practices, Regulated Industry, Clinical Affairs, Regulatory Requirements, Chemistry, Quality System, Good Laboratory Practice (GLP), Regulatory Submissions, Global Regulatory Compliance, Biology

Experience

Regulatory Affairs Associate

Network Partners Group

2024-6 - Present · 2 yrs 4 mos

Key Contributions: • Understanding of how to identify and manage regulatory risks and challenges, including navigating regulatory changes and enforcement actions. • Insightful on how regulatory bodies align with business goals, including market entry and lifecycle management. • Support in researching regulatory changes and updates that may impact the company and share relevant insights with the team. • Developing and analyzing internal Regulatory intelligence database.

Regulatory Affairs and Quality Associate

Network Partners Group

2024-6 - Present · 2 yrs 4 mos

Labeling Associate

Nutrition Formulators

2023-10 - 2023-12 · 3 mos

Miramar, Florida, United States

Key Contributions: • Ensured compliance with FDA regulations and guidelines for dietary supplements, nutraceutical, and veterinary products. • Developed and conducted thorough reviews of product labels, including ingredient lists, nutrition facts, and health claims. • Resolved labeling discrepancies and issues promptly to avoid regulatory penalties.

Laboratory Analyst

Priority Lab

2022-10 - 2023-1 · 4 mos

Fort Lauderdale, Florida, United States

Key Contributions: • Prepared and processed mold samples for slide analysis, ensuring adherence to quality control standards and maintaining accurate documentation within the quality management system. • Performed quantitative and qualitative analyses and identifications on mold samples, leading to more precise contamination assessments. • Collaborated with cross functional teams to integrate mold analysis results into comprehensive environmental assessments. • Maintained and calibrated laboratory equipment, ensuring optimal performance and adherence to safety protocols.