Senior Specialist, CMC Regulatory Affairs

Title : CMC Regulatory Affair Specialist

Location : Seattle, WA (Hybrid)

Duration : 6 Months

Job Description

• Candidates submitted should be flexible to work from either the Seattle site, 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.
• 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 :

MBA or MSc with a minimum of 2 years' experience

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