E. Musa Kyeba

About E. Musa Kyeba

I have over 9 years of working in FDA regulated environments, with experience in Regulatory Affairs, Quality Assurance Quality Control, Environmental Monitoring, Validation, Aseptic Manufacturing, Supplier Quality, Device and Product Packaging Materials testing. I am currently a Regulatory Affairs professional responsible for maintaining registrations for existing products in compliance with applicable global regulations. I am also responsible for insuring all site change controls are appropriately assessed for local and global regulatory impact, acting as the site liaison with corporate regulatory affairs to plan and implement change controls and preparing site documentation in support of change controls. My previous position as a Quality Engineer Investigator required working closely and partnering with Manufacturing, Quality Assurance, Validation, Production, Chemical Quality and Maintenance departments on a daily basis to write and resolve Manufacturing and Quality Control deviations and implement Corrective and Preventive Actions. In addition, I have broad and in-depth knowledge of the various aspects of cGXP (GMP, GCP and GLP), FDA regulations and regulatory compliance.

Experience

1. Regulatory Affairs

   Pfizer

   Jun 2015 — Present · Raleigh-Durham, NC, US

   Evaluates manufacturing changes for global regulatory impact and ensures compliance with applicable global regulations. This includes accurately describing the changes for ease of regulatory agency review. • Manages the preparation of registration packages and negotiates submission data requirements and deliverable dates with internal technical teams. • I am a member of a team that develops regulatory strategies for manufacturing improvements. Analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities. • Maintains awareness of regulatory legislation and assesses its impact on business practices in the manufacturing environment. • Reviews site procedures and policies for regulatory impact • Supports site GMP certification and license to manufacture activities. • Assesses site change controls for US and global regulatory impact.

Education

• Durham Technical Community College

  Clinical Trials Associate, Clinical Research

  2007 — 2008

• The Johns Hopkins University

  Master of Science (MS), Regulatory Science

  2009 — 2012

• St. Augustine's College

  Bachelor of Science (B.S.), Chemistry

  1996 — 2001