Director, Regulatory Affairs

Sr. Director, Regulatory Labeling and Advertising Promotion 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. 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 Sr. Director, Regulatory Labeling, Advertising & Promotion (LAP) is responsible for leading global product labeling and U.S. advertising and promotion regulatory activities across the company’s portfolio. This role provides strategic and operational leadership to ensure labeling and promotional materials are scientifically accurate, compliant with regulatory requirements, and aligned with corporate and commercial objectives. The position serves as a key regulatory partner to Clinical Development, Medical Affairs, Commercial, Legal, and Safety, and plays a central role in labeling strategy, lifecycle management, and promotional material review in a highly regulated environment, for cell and gene therapy products. This is a full-time hybrid position (3 days a week) in our Somerville - Assembly Row, Massachusetts office. Job Duties and Responsibilities Core Responsibilities : Labeling Lead the development, negotiation and lifecycle maintenance of global and US product labeling, including pre- and post- approval updates. Drive development and maintenance of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI), ensuring alignment with global regulatory expectations. Establish and operationalize labeling strategies that result in clear, concise, compliant and scientifically robust product labels. Provide regulatory leadership for labeling-related interactions with Health Authorities, including briefing documents and responses to inquiries. Ensure final labeling content meets internal standards and regulatory authority requirements prior to submission or implementation. Advertising and Promotion Oversee regulatory review of US promotional and select non-promotional materials. across channels, ensuring compliance with FDA regulations and enforcement trends Serve as the regulatory lead and reviewer for Medical-Legal-Regulatory (MLR) review. Partner with Commercial, Medical Affairs and Legal to proactively identify and mitigate regulatory risk in promotional strategy and execution. Monitor and interpret FDA enforcement actions and policy developments related to advertising and promotion, translating insights into internal guidance and best practices. Develop submission strategy for efficient and appropriate health authority review of promotional materials; and ensure the compliant and timely submission of promotional materials to Health Authorities. Create and manage promotional submissions documents in the electronic database and partner with Regulatory Operations on submissions. Governance, Process and Compliance Support or co-lead the Labeling Review Committee (LRC) and provide regulatory oversight of labeling governance processes. Develop, maintain, and improve SOPs, workflows, tools, and training related to labeling and Ad/Prom review. Ensure inspection readiness and documentation compliance for labeling and promotional activities. Drive consistency and operational excellence across labeling and Ad/Prom processes globally. Cross-Functional Leadership Act as a strategic regulatory advisor to Clinical, Safety, Medical Affairs, Commercial, Quality, and Regulatory Strategy teams. Lead and mentor internal staff and manage external vendors or consultants as needed. Contribute to broader regulatory strategy discussions. Essential/Required Qualifications : Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies. Experience supporting FDA interactions related to labeling and promotional compliance Experience with MLR review and developing Company Core Data Sheets Prior experience in cell and gene therapy or rare disease is strongly preferred. Proven ability to lead cross-functional teams and to operate in a matrixed organization, including leadership without direct authority. Excellent written and verbal communication skills. Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree) Preferred Qualifications : Prior experience in cell and gene therapy or rare disease is strongly preferred. Ability to influence without authority and partner effectively with senior leaders. Strong attention to detail and accuracy with sound judgement and risk-based decision making. Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines, motivates others, demonstrates tact and diplomacy, and has a flexible and positive solution-oriented approach. Deep understanding of FDA regulations and guidance governing labeling and promotional materials. An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts. 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. Pay Transparency $238,000 - $294,000 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. #J-18808-Ljbffr