Sr. Director, Regulatory CMC
Genetix Biotherapeutics
About this role
The Senior Director, Regulatory CMC at Genetix Biotherapeutics is responsible for defining and executing global regulatory strategies for gene therapy products, primarily focusing on lifecycle management, compliance, and post-approval activities. The role provides strategic leadership and ensures alignment between regulatory requirements and operational execution for complex biologics.
Skills
Qualifications
About Genetix Biotherapeutics
genetixbiotx.comGenetix Biotherapeutics (formerly bluebird bio) is a biopharmaceutical company focused on developing and delivering transformative genetic therapies for people living with sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy. The company advances clinical programs and patient support services to bring novel gene-based treatments to individuals with severe inherited blood and neurological disorders. Headquartered in Somerville, MA, Genetix provides medical information, runs clinical trials, and offers dedicated patient support and outreach.
Recent company news
Business WireGenetix Announces 2025 Commercial Performance Results and Outlines 2026 Strategic Priorities
3 days ago
Fierce PharmaAfter buyout, bluebird bio hatches familiar new branding as Genetix Biotherapeutics
Sep 18, 2025
BioSpaceBye Bye Bluebird: Gene Therapy Biotech Emerges From Private Buyout With Rebrand
Sep 19, 2025
Managed Healthcare ExecutiveGene therapy in the real world: High priced, a long process and still relatively few patients | ASH 2025
Dec 6, 2025
PR NewswireMinaris and Genetix Biotherapeutics Expand Manufacturing Partnership to Support Commercial Supply for LYFGENIA™ (lovotibeglogene autotemcel)
1 month ago
About Genetix Biotherapeutics
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
Unlock Company Insights
View leadership team, funding history,
and employee contacts for Genetix Biotherapeutics.
Salary
$270k – $285k
per year
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