Akhil Sunkari, PharmD, MS, RAC

Regulatory Affairs Specialist @ ScieGen Pharmaceuticals Inc

Country

City

United States

Industry

Pharmaceuticals

Skill

Adverse Events, U.S. Food and Drug Administration (FDA), Regulatory Standards, Adverse Event Reporting, Communication, Confidentiality, Good Clinical Practice (GCP), Product Development, Biostatistics, Clinical Operations, Good Manufacturing Practice (GMP), Corrective and Preventive Action (CAPA), Attention to Detail, PV, Safety Management, Contract Research Organization (CRO), Key Performance Indicators, Oncology Clinical Research, Cardiology Clinical Trails, Regulatory Compliance

Experience

Regulatory Affairs Specialist

ScieGen Pharmaceuticals Inc

2025-7 - Present · 1 yr 3 mos

Clinical Safety Specialist

Aeternus Solutions

2025-1 - 2025-5 · 5 mos

Clinical Research Associate

Evon Medics, LLC

2024-4 - 2025-1 · 10 mos

Baltimore, Maryland, United States

Regulatory Affairs Extern

China Med Device

2023-9 - 2023-12 · 4 mos

Boston, Massachusetts, United States

Regulatory Affairs Intern

Aeternus Solutions

2023-4 - 2023-9 · 6 mos

Pharmacovigilance Specialist

Cognizant

2019-10 - 2021-12 · 2 yrs 3 mos

Clinical Research Associate

Cliniserve, India

2018-6 - 2019-9 · 1 yr 4 mos

Conducted and monitored clinical trials as per regulatory requirements Evaluated the quality and integrity of study site practices related to protocol and applicable regulations. Managed the progress of assigned studies by tracking regulatory submissions and approvals. Reviewed complete study documents to ensure the correctness of data Reviewed patient dairy/clinical notes along with case report forms to ensure the correctness of data. Reviewing Site master file documents, screening records, informed consent documents, case report forms and other source documents. Escalated quality issues to CPM.