10-12 years of biopharmaceutical industry experience
Experience with post-approval CMC submissions and regulatory interactions
Strong understanding of commercial manufacturing and lifecycle management
Solid knowledge of GMP and global regulatory frameworks
Strong communication skills for regulatory documentation
Ability to thrive in cross-functional, matrix environments
Responsibilities
Lead post-approval CMC lifecycle management activities
Support CMC change management strategies and regulatory pathways
Manage regulatory CMC activities for manufacturing and inspections
Contribute to regulatory interactions with global health authorities
Partner with teams to align regulatory strategies with operational plans
Author and review CMC documentation for regulatory compliance
Ensure adherence to global CMC regulatory standards
Monitor regulatory intelligence on post-approval guidance
Mentor junior Regulatory CMC team members
Represent Regulatory CMC on cross-functional teams
Benefits
Comprehensive health, life, and disability insurance
Employer-matched 401(k) plan
Flexible time-off and paid holidays
Tuition reimbursement and loan repayment assistance
Paid parental leave and onsite parking
Commuter subsidy and lifestyle spending account
Annual bonus and long-term incentive opportunities
Full Job Description
The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for approved and late-stage gene therapy products, with a primary focus on lifecycle management, change management, and regulatory compliance. This role supports the development and delivery of post-approval regulatory strategies and ensures effective implementation of manufacturing, analytical, and control changes across global markets.
The Director partners closely with Technical Operations, Quality, and Supply Chain to ensure alignment between regulatory requirements and operational execution. 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. Specific Job Duties
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
Required Education, Experience, or Qualifications
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
Strong understanding of commercial manufacturing and lifecycle management for complex biologics and/or gene therapy products
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
Additional Information
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. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.
Genetix's total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.
