CMC Change Control


New York, NY

Industry: Biotech/Pharma


Less than 5 years

Posted 414 days ago

  by    Nancy Christie

This job is no longer available.

Regulatory Affairs Change Control Specialist


Our client is a leader in pharmaceutical solutions and is seeking to hire Regulatory Affairs Change Control Specialist responsible for CMC submissions deliveries and Global Regulatory Affairs and Clinic Safety system and process maintenance. In this role, you will compile and summarize CMC information and data to support regulatory affairs submissions and maintain regulatory tools/databases.

  • Responsibilities:
  • Plan and create CMC submissions project plans
  • Oversee project deliverables in all phases of submission prep i.e. authorization, assessment, execution, etc. and ensure completion
  • Support of operational change control activities and dossier preparations
  • new product registration or post approval changes, annual reports
  • Partner w/ Chemistry, Manufacturing, and Controls scientists gathering information in support of change assessments and strategies
  • Resolve any project challenges
  • Development and continuous improvement of processes, systems and metrics
  • Assist with submission preparation, development, formatting/editing, etc.
  • Comply with Department and Company Standard Operating Procedures


  • Bachelor's Degree preferably in Science or Engineering
  • Min. 3+ years’ experience in Pharmaceutical industry prefer (Vaccine)
  • Experience in project management methodologies (PMP, Sigma and or Change etc.)
  • Knowledge/Understanding of change control requirements and regulatory information
  • Previous experience in Regulatory Affairs
  • Experience with document management systems and document sharing systems
  • Knowledge/Understanding of CMC and CTD structure/content
  • Ability to prioritize & multi-task
  • Strong communication & project management skills
  • Advanced proficiency in Microsoft Office – Word, Excel, PowerPoint, MS Project and Adobe Acrobat
  • Regulatory systems strongly preferred


  • 18 month Contract
  • $40.00 - $50.00/hour
$83K - $104K