Director/Sr. Director, US Regulatory Advertising and Promotion

Genetix Biotherapeutics; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Genetix Biotherapeutics seeks a senior regulatory leader to oversee promotion review for cell and gene therapy products. The role requires coordinating with Medical, Legal and Commercial teams to ensure FDA compliance and risk mitigation.

Based in Somerville, MA, this full-time hybrid position combines strategic submissions with hands-on review of materials and SOP improvements. Strong leadership and communication are essential.

Qualifications

• Advanced degree plus 10+ years in biotech/pharma regulatory roles.
• Experience supporting FDA interactions and MLR reviews is required.
• Cell/gene therapy or rare diseases experience is highly desirable.

Responsibilities

• Oversee review of promotional materials and non-promotional content.
• Serve as regulatory lead in Medical-Legal-Regulatory reviews.
• Collaborate with Commercial, Medical Affairs, and Legal to mitigate regulatory risks.
• Develop submission strategies for regulatory filings and interactions.
• Monitor FDA enforcement trends and adapt strategies accordingly.
• Establish and improve SOPs, workflows, and training for promotional review processes.

Skills

FDA regulatory knowledge

Cross-functional leadership

Problem solving

Clear communication

Risk-based judgment

Education

Advanced degree (PharmD/PhD/MD/JD)

Job description

Role

Lead regulatory advertising and promotion activities for cell and gene therapy products at Genetix Biotherapeutics, ensuring compliance with FDA regulations.

Responsibilities

• oversee review of promotional/non-promotional materials
• serve as regulatory lead in Medical-Legal-Regulatory reviews
• partner with Commercial, Medical Affairs, and Legal to mitigate regulatory risks
• develop submission strategies
• monitor FDA enforcement trends
• establish and improve SOPs, workflows, and training related to promotional review

Qualifications

• advanced degree (PharmD, PhD, MD, JD) preferred; 10+ years of regulatory experience in biotech or pharma, especially supporting FDA interactions and MLR review; experience in cell/gene therapy or rare diseases highly desirable.

Skills

• deep understanding of FDA promotional regulations
• leadership in cross-functional teams
• problem-solving ability
• excellent communication
• risk-based judgment

Work setup: full-time hybrid role based in Somerville, MA, with onsite presence required three days/week.