About the role
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.
This is a full-time hybrid position based in our Somerville, Massachusetts (Assembly Row) office, with an onsite presence required three days per week. Candidates must reside within a commutable distance of the office to be considered.
Position Description:
The Director, US Regulatory Advertising & Promotion is responsible for leading U.S. advertising and promotion regulatory activities across the company’s portfolio. This role provides strategic and operational leadership to ensure promotional materials are compliant with regulatory requirements and aligned with corporate and commercial objectives.
The Director serves as a key regulatory partner to Medical Affairs, Commercial, Marketing, and Legal, and plays a central role in promotional material review in a highly regulated environment, for cell and gene therapy products.
Job Duties and Responsibilities:
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
* Develop, maintain, and improve SOPs, workflows, tools, and training related to Ad/Prom review. * Escalate issues related to MLR reviews and approvals, as needed. * Drive consistency and operational excellence.
Essential/Required Qualifications:
* Advanced degree (PharmD, PhD, MD, JD or equivalent degree) preferred, but not required. * Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies. * Experience supporting FDA interactions related to promotional compliance * Experience with MLR review * 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. * Deep understanding of FDA regulations and guidance governing promotional materials * An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts. * Excellent English written and verbal communication skills. * 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.
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 $185,000—$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.