Nicole Shepard

Regulatory Affairs Director @ AstraZeneca

Country

United States

City

Washington DC-Baltimore Area

Industry

Pharmaceuticals

Skill

Clinical Trials, Project Management, FDA, Pharmaceutical Industry, Regulatory Submissions, Drug Development, Clinical Development, GCP, EDC, Biotechnology, Clinical Research, Project Finance, Regulatory Affairs, CRO, U.S. Food and Drug Administration (FDA)

Experience

Regulatory Affairs Director

AstraZeneca

2020-1 - Present · 6 yrs 9 mos

Associate Regulatory Project Director

AstraZeneca

2018-8 - 2019-12 · 1 yr 5 mos

Global Regulatory Affairs Project Manager

AstraZeneca

2016-5 - 2018-8 · 2 yrs 4 mos

Senior Project Manager

Cato Research

2015-12 - 2016-5 · 6 mos

Strategically managed and coordinated all phases of the project life cycle for global projects. Experience includes clinical trial management and regulatory strategy. Authored, compiled, and submitted both electronic and paper regulatory documents, including requests for Types A, B, and C Agency Meetings, Investigational New Drug (IND) Applications, Orphan Drug Applications (ODAs), New Drug Applications (NDAs), Biologic Master Files (BMFs), and Investigational Medicinal Product Dossiers (IMPDs). Strategic preparation and participation at numerous face to face Food and Drug Administration (FDA) meetings. Therapeutic areas of experience include infectious diseases, hematology, oncology, respiratory, metabolic diseases, and neurological disorders.