Sr. Director, Regulatory CMC

Genetix Biotherapeutics; Somerville (MA); Hybrid; USD 270,000 - 285,000; Full time

Benefits offered by this job

Unlimited paid time off

Comprehensive medical benefits

Parental leave

401k

Job summary

A leading biotechnology firm in Somerville, Massachusetts, is looking for a Senior Director, Regulatory CMC. This role is pivotal in defining and executing global CMC regulatory strategies for gene therapy products while ensuring compliance. Responsibilities include driving CMC activities, regulatory submissions, and mentoring team members. The ideal candidate will have substantial experience in regulatory affairs and possess a deep understanding of industry regulations. This full-time hybrid position offers a competitive salary of $270,000 - $285,000 and robust benefits including unlimited paid leave.

Qualifications

• 15+ years of experience in biopharmaceutical industry.
• Experience with post-approval regulatory submissions.
• Strong understanding of GMP and CMC regulations.

Responsibilities

• Lead post-approval CMC lifecycle management activities.
• Drive global CMC change management strategy.
• Serve as primary regulatory CMC lead for health authority interactions.

Skills

Leadership

Regulatory knowledge

Communication skills

Project management

Analytical thinking

Education

Master’s or PhD in life sciences

Job description

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

Position Description

The Senior Director, Regulatory CMC is responsible for defining and executing global CMC regulatory strategy for approved and late-stage gene therapy products, with a strong emphasis on lifecycle management, change management, and sustained regulatory compliance. This role provides strategic regulatory leadership across Genetix programs, ensuring efficient implementation of post-approval manufacturing, analytical, and control changes while maintaining product supply and inspection readiness.

The Senior Director serves as a key regulatory partner to Technical Operations, Quality, and Supply Chain, and acts as the primary CMC regulatory interface with global health authorities for post-approval activities, including supplements, variations, annual reports, and inspection support.

This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office.

Specific Job Duties

• Provide strategic leadership for post-approval CMC lifecycle management activities for Genetix gene therapy products, including planning and execution of global supplements, variations, and annual regulatory filings
• Own and drive global CMC change management strategy, assessing manufacturing, analytical, raw material, facility, and control strategy changes and defining optimal and aggressie regulatory pathways for implementation
• Lead regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness, including responses to health authority questions and commitments
• Serve as the primary regulatory CMC lead for post-approval health authority interactions, including Type C/Scientific Advice meetings, responses to information requests, and support of GMP inspections
• Partner closely with Pharmaceutical Sciences, Technical Operations, Quality, Supply Chain, and Program Teams to ensure alignment between regulatory strategy and operational execution
• Provide regulatory oversight and approval of post-approval CMC documentation, ensuring consistency with approved dossiers and global regulatory requirements
• Drive adherence to global CMC regulatory standards and guidance (FDA, EMA, ICH) applicable to commercial and post-approval gene therapy products
• Contribute to and lead regulatory intelligence efforts related to post-approval expectations, emerging guidance, and evolving inspection trends impacting gene therapy products
• Mentor and develop Regulatory CMC team members, building scalable post-approval regulatory capabilities to support Genetix portfolio growth
• Represent Regulatory CMC on cross-functional governance forums, providing clear, risk-based regulatory recommendations

Required Education, Experience, or Qualifications

• Bachelor’s or Master’s degree in life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field); PhD preferred
• Minimum of 15 years of biopharmaceutical industry experience, with significant experience in post-approval CMC regulatory affairs for cell and gene therapies
• Demonstrated experience leading post-approval submissions, including supplements, variations, and annual reports, and supporting health authority GMP inspections
• Strong working knowledge of commercial manufacturing and lifecycle management for complex biologics and gene therapy products
• Excellent written and verbal communication skills with proven ability to translate complex technical issues into clear regulatory strategies
• Proven leadership skills, including strategic thinking, people development, cross-functional influence, and decision-making in a matrix environment
• Deep understanding of GMP, CMC regulatory requirements, and global regulatory frameworks (FDA, EMA, ICH)
• Highly organized, detail-oriented, and solution-focused, with the ability to manage multiple priorities and drive execution to completion

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

Pay Transparency

$270,000 - $285,000 USD

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

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