Director, Regulatory CMC — Gene Therapy Global Submissions

Dispatch Bio; Philadelphia (Philadelphia County); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Equity

Medical, Vision, and Dental

401(k) plan

Life Insurance

Flexible PTO

Additional benefits

Job summary

Dispatch Bio is seeking a Director/Executive Director, Regulatory CMC to lead global regulatory CMC strategy and execution across our cell and gene therapy portfolio. You will partner with cross-functional teams and health authorities to drive submissions and compliance across development stages, in a fast-moving startup environment.

The role reports to the Vice President, Head of Regulatory Affairs and requires deep CMC expertise, strong leadership, and the ability to mentor others while

Qualifications

• Bachelor's degree in life sciences, chemistry, engineering, or related discipline.
• Minimum of 10 years of regulatory CMC experience within biotech or pharma.
• Direct, hands-on experience authoring/managing CMC sections of IND, BLA, or MAA submissions.
• Direct experience with cell therapy, viral vector, or ATMP manufacturing.
• Deep working knowledge of FDA and ICH CMC regulations for biologics; cell/gene therapy.
• Experience leading CMC-focused health authority interactions and correspondence.
• Track record managing complex manufacturing regulatory strategy, including comparability and post-approval changes.
• Strong leadership, influence across cross-functional stakeholders without direct authority.
• Excellent written and verbal communication with high attention to detail.
• Ability to operate effectively in a fast-moving startup environment.

Responsibilities

• Lead global regulatory CMC strategies from early development through licensure.
• Author, review, and approve CMC sections of regulatory submissions (INDs, CTAs, BLAs/MAAs).
• Serve as primary regulatory CMC liaison to health authorities (FDA, EMA, TGA).
• Collaborate with Process Development, Manufacturing, Analytical Development, and Quality.
• Provide regulatory guidance on manufacturing changes and process validation.
• Assess regulatory risk and advise senior leadership on mitigations.
• Track evolving global CMC guidance and policy trends for cell/gene therapy.
• Manage relationships with CDMOs and external testing laboratories.
• Build, mentor, and develop regulatory CMC talent as the team grows.
• Represent Regulatory CMC on cross-functional program teams and report to leadership.

Skills

CMC regulatory

Leadership

Regulatory strategy

FDA/ICH knowledge

Regulatory submissions

Communication skills

Startup environment

Cross-functional collaboration

Education

Bachelor's degree

MS/PhD/PharmD (preferred)

Job description

Dispatch Bio is seeking a Director/Executive Director, Regulatory CMC to lead global regulatory CMC strategy and execution across our cell and gene therapy portfolio. You will partner with cross-functional teams and health authorities to drive submissions and compliance across development stages, in a fast-moving startup environment.

The role reports to the Vice President, Head of Regulatory Affairs and requires deep CMC expertise, strong leadership, and the ability to mentor others while