Davison Ejiogu

About Davison Ejiogu

Chemistry, Manufacturing and Controls (CMC) technical writing and communication in pharmaceutical manufacturing, regulatory, quality control and quality assurance. • Work with Product development, process validation and CMC documentation for various dosage forms.• Write reports or CMC regulatory content or Quality Investigations and interact with a multi-disciplined team. • Work with standardized templates and familiarity with US and International regulatory submissions. • Provide regulatory assessment of post-approval CMC changes for assigned FDA approved NDA drug products in accordance with current FDA regulations and guidance; author and compile CMC dossiers for NDA supplements, annual reports, phase IV IND, and DMF Annual updates for assigned products in eCTD format. • Ensure all dossiers follow appropriate SOPs, guidance, GXP and ICH guidance and maintain up to date knowledge. Communicate with Quality and manufacturing site teams to request necessary content and documentation for regulatory submissions• Work with change control systems, and authoring and reviewing FDA post-approval CMC changes requiring eCTD format for submissions.• Work closely with quality, manufacturing, regulatory and technical staff from global locations and with external contractors to communicate, coordinate and track required documentation in support of new and post-approval CMC regulatory activities. • Contribute to various projects by planning, writing and delivering agreed submission deliverables for US, EU and rest of world (ROW) registrations. • Work with change control systems, authoring and reviewing FDA post-approval CMC changes requiring eCTD format for submissions.• Worked with multi-disciplined teams in the bio-pharmaceutical industry and with internal and external partners.

Experience

1. Cmc Regulatory Technical Writer Us Industrial Development Affairs

   Sanofi

   Jan 2018 — Present

   Supporting the US Industrial/External Development Affairs Team with Emphasis on supporting CMC Regulatory Writing and Pharmaceutical Development/Project Management.

Education

• Grand Canyon University

  Master's degree, Master of Education in Sec. Ed. with STEM

• Buffalo State University

  Bachelor of Science (BS), Biology/Chemistry

  1999 — 2003

• Raritan Valley Community College

  Associate of Science - AS, Biotechnology, AS-Science & Mathematics, AS-Pre-Medical Professional,

  2007 — 2011

• Grand Canyon University

  Bachelor of Applied Science - BASc, Applied Sciences

Skills

• Standard Operating Procedure (Sop)
• Laboratory
• U.s. Food and Drug Administration (Fda)
• Good Laboratory Practice (Glp)
• Quality System
• V&V
• Technical Writing
• Elisa
• Biotechnology
• Quality Assurance
• Cell Culture
• Hplc
• Capa
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Affairs
• Lifesciences
• Purification
• Manufacturing
• Glp
• Pharmaceutics
• Validation
• Biochemistry
• Chemistry
• Gmp
• Vaccines
• Verification and Validation (V&V)
• Pcr
• Technology Transfer
• Corrective and Preventive Action (Capa)
• Life Sciences
• Formulation
• Chromatography