Regulatory Advertising & Promotion Director (CGT)

Genetix Biotherapeutics Inc.; Somerville (MA); Hybrid; USD 185,000 - 285,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Health insurance

401(k) plan

Paid holidays

Parental leave

Commuter subsidy

Job summary

Genetix Biotherapeutics is seeking a Director, Regulatory Advertising & Promotion to lead U.S. advertising and promotion regulatory activities across the portfolio.

The role provides strategic and operational leadership to ensure promotional materials comply with FDA regulations and align with commercial objectives. You will partner with Medical Affairs, Commercial, Marketing and Legal as regulatory lead for MLR reviews, oversee submissions, risk mitigation, and drive governance improvements

Qualifications

• Advanced degree or equivalent with strong scientific background.
• "Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies."

Responsibilities

• Lead regulatory review of US promotional materials across channels, ensuring FDA compliance.

Skills

Regulatory leadership

FDA experience

MLR review

Cross-functional leadership

Matrix organization

Communication skills

Problem-solving

Education

Advanced degree (PharmD/PhD/MD/JD or equivalent)

Tools

FDA regulations

Job description

Genetix Biotherapeutics is seeking a Director, Regulatory Advertising & Promotion to lead U.S. advertising and promotion regulatory activities across the portfolio.

The role provides strategic and operational leadership to ensure promotional materials comply with FDA regulations and align with commercial objectives. You will partner with Medical Affairs, Commercial, Marketing and Legal as regulatory lead for MLR reviews, oversee submissions, risk mitigation, and drive governance improvements