Director, Regulatory CMC — Cell & Gene Therapy (Hybrid)

Dispatch Biotherapeutics, Inc.; San Francisco, Northern (CA, KY); Hybrid; USD 240,000 - 320,000; Full time

Benefits offered by this job

Equity ownership

Medical, vision, and dental

401(k) with generous contribution

Life insurance

Flexible PTO

Additional benefits

Job summary

Dispatch Biotherapeutics, Inc. is seeking an Executive Director, Regulatory CMC to lead the regulatory CMC strategy across our cell and gene therapy pipeline.

The role reports to the VP, Regulatory Affairs and involves both strategic planning and hands-on execution for global development programs through early to late-stage development. The role requires deep knowledge of FDA/ICH CMC regulations, extensive experience with IND/BLA/MAA submissions, and a track record of coordinating

Qualifications

• Bachelor's degree required in life sciences or related field.
• 10+ years of regulatory CMC experience in biotech/pharma.
• Direct authoring/management of CMC sections (IND, BLA, MAA, etc.).
• Experience with cell therapy, viral vectors, or ATMP manufacturing.

Responsibilities

• Lead global regulatory CMC strategy and execution for cell/gene therapy programs.
• Author/review CMC sections for regulatory submissions and updates.
• Serve as primary CMC liaison to FDA, EMA, and other authorities.
• Collaborate with Process Development, Manufacturing, Analytical Development, and Quality.

Skills

Regulatory CMC leadership

CMC submissions

Health authority liaison

Leadership

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree in life sciences, chemistry, engineering, or related discipline

Job description

Dispatch Biotherapeutics, Inc. is seeking an Executive Director, Regulatory CMC to lead the regulatory CMC strategy across our cell and gene therapy pipeline.

The role reports to the VP, Regulatory Affairs and involves both strategic planning and hands-on execution for global development programs through early to late-stage development. The role requires deep knowledge of FDA/ICH CMC regulations, extensive experience with IND/BLA/MAA submissions, and a track record of coordinating