Senior Regulatory Affairs Specialist, CMC

623571 Senior Specialist, Regulatory Affairs, CMC

6-month contract

Seattle or Bothell, WA - candidates should be flexible to work from either the Seattle or Bothell site in WA. This is a hybrid position, candidates are required to be onsite Mondays and Thursdays at either one of those locations.

Duties

• Support preparation, review, and submission of CMC sections for U.S. and global regulatory filings, including INDs / CTAs, amendments, and BLAs / MAAs.
• Coordinate with internal stakeholders to gather technical information and ensure accuracy and consistency across CMC documentation.
• Assist in developing and maintaining submission plans for assigned programs.
• Review change controls and manufacturing documentation to assess regulatory impact.
• Track and interpret evolving regulatory requirements and guidance relevant to cell and gene therapy manufacturing, testing, and control.
• Support interactions with domestic and global health authorities, including preparation of meeting materials, responses to information requests, and briefing documents.
• Maintain regulatory databases, document systems, and submission archives in compliance with internal procedures.
• Contribute to continuous improvement initiatives within the Regulatory Affairs CMC function.

Skills

Education

Pay Rate Range : $60-72 / hr depending on experience