Genetix Biotherapeutics
Director, Regulatory CMC
Somerville, MA · Director · Full-time
Sponsorship not specifiedDetected 22 days ago
Supply ChainGMPFDA RegulatoryCRISPRCommunicationMentoringOrganizational SkillsRegulatory Affairs
About the role
- This is personal and we approach every challenge with radical care.
- This individual contributes to regulatory interactions with health authorities and plays a key role in supporting post-approval submissions, inspection readiness, and ongoing compliance activities.
- This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office.
Compensation
- $204,000 - $245,000 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
- Lead execution of post-approval CMC lifecycle management activities, including preparation and submission of global supplements, variations, and annual reports
- Support development and implementation of CMC change management strategies, assessing manufacturing, analytical, raw material, facility, and control changes and recommending appropriate regulatory pathways
- Manage regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness, including drafting responses to health authority questions and commitments
- Contribute to regulatory interactions with global health authorities (e.g., FDA, EMA), including support for meetings, information requests, and inspection activities
- Partner with Technical Operations, Quality, Supply Chain, and Program Teams to ensure regulatory strategy aligns with operational plans and timelines
- Author and review post-approval CMC documentation, ensuring consistency with approved dossiers and global regulatory requirements
- Ensure adherence to global CMC regulatory standards and guidance (FDA, EMA, ICH) applicable to commercial and post-approval gene therapy products
- Monitor and apply regulatory intelligence related to post-approval expectations, emerging guidance, and inspection trends
- Provide mentorship and guidance to junior Regulatory CMC team members as appropriate
- Represent Regulatory CMC on cross-functional teams and provide clear, risk-based regulatory input to support decision-making
- Bachelor's or Master's degree in life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field)
- Minimum of 10-12 years of biopharmaceutical industry experience, with relevant experience in CMC regulatory affairs for biologics or gene therapy products
- Experience supporting post-approval CMC submissions (e.g., supplements, variations, annual reports) and regulatory interactions
- Strong understanding of commercial manufacturing and lifecycle management for complex biologics and/or 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.
- Solid knowledge of GMP, CMC regulatory requirements, and global regulatory frameworks (FDA, EMA, ICH)
- Strong written and verbal communication skills, with the ability to translate technical information into clear regulatory documentation
- Demonstrated ability to work effectively in cross-functional, matrixed environments
- Strong organizational skills and ability to manage multiple priorities in a fast-paced environment
Equal opportunity
- Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.
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