Genetix Biotherapeutics

Genetix Biotherapeutics

Sr. Director, Regulatory CMC

Somerville, MA · Director · Full-time

Sponsorship not specified$156k-$317kDetected 84 days ago
Supply ChainGMPFDA RegulatoryCRISPRLeadershipCommunicationOrganizational SkillsRegulatory Affairs

About the role

  • This is personal and we approach every challenge with radical care.
  • 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.
  • This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office.

Compensation

  • $156,000 - $316,500 USD
  • The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting.

Benefits

  • This role is eligible for an annual bonus and long-term incentive.
  • Genetix's total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs.

Company info

  • 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
  • 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
  • About Genetix Biotherapeutics
  • 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.
  • 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

Equal opportunity

  • Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.
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