Director, US Regulatory Advertising and Promotion

🏢 Genetixbiotherapeutics · 📍 Somerville, MA · 💼 hybrid 💰 $185,000 - $185,000 / yr

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Position Summary & Responsibilities

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

🎯 Candidate Preparation Guide For Genetixbiotherapeutics Applicants

Key Role Competencies & Evaluation Highlights

Key Role Focus:

Rigorous scientific precision, unwavering commitment to regulatory compliance, and translational drug development capability.

📋 Preparation Priorities (Key Areas to Clarify):

1. Handwaving over critical experimental controls or reproducibility issues.
2. Disregard for cross-functional bottlenecks between R&D and clinical teams.
3. Overhyping early-stage pre-clinical results.

✨ Recommended Role Alignment Hook:

My background combines rigorous genomic science with a relentless focus on accelerating clinical translation safely.

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