Regulatory Specialist (Document Control - CMC & Bioanalytical)

Location
San Diego, California
Posted
Aug 14, 2018
Ref
#877198
Required Education
Bachelors Degree
Position Type
Full time

Regulatory Specialist (Document Control - CMC & Bioanalytical)

Our client, a growing innovator in the biopharma industry, is seeking a Regulatory Document Control Specialist to join their winning team! The Document Control Specialist will work side by side with the Global Head of Quality and C-level officers to organize, maintain, upgrade, create, and implement document processes.

Responsibilities:

  • Assess Chemistry Manufacturing and Controls (CMC) and bioanalytical documents generated to date and implement archival and retrieval structure for electronic and/or paper documents.
  • Ensure that all CMC and bioanalytical documentation required by regulatory authorities for Phase 2 initiation is available.
  • Compile and organize executed Batch Records from CMOs into binders and in electronic format to ensure document completeness and security.
  • Organize Technical Reports, raw data, SOPs, qualification reports and relevant documents to ensure these are easily retrievable.
  • Ensure location of each paper and electronic document is maintained and kept current.
  • Assist with other Document Control functions.

Knowledge, Experience, and Skill:

  • 5 plus years of experience in Document Management in a FDA regulated company.
  • Knowledge of CMC Section and FDA submissions for antibody therapeutics.
  • Excellent organizational and communication skills.
  • Must be detail oriented.