Director, Regulatory Advertising & Promotion

Adweek; Somerville (MA); Hybrid; USD 185,000 - 285,000; Full time

Benefits offered by this job

Bonus eligibility

Long-term incentive

Comprehensive benefits

Job summary

Genetix Biotherapeutics seeks a Director of Regulatory Advertising & Promotion to lead U.S. regulatory activities for promotional materials across the portfolio. You will partner with Medical Affairs, Commercial, Marketing and Legal to ensure compliant strategies and timely health authority submissions.

The role requires 10+ years in biotech/pharma regulatory, with strong MLR and FDA experience, and excellent communication in a matrixed organization.

Qualifications

• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent) and strong scientific background.
• 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.
• Excellent English written and verbal communication skills.

Responsibilities

• Oversee regulatory review of US promotional materials across channels for FDA compliance.
• Lead MLR reviews with Medical, Legal, and Regulatory teams.
• Partner with Commercial, Medical Affairs and Legal to manage regulatory risk.
• Monitor FDA enforcement actions and translate into internal guidance.
• Develop submission strategy for health authority reviews and timely submissions.
• Create and manage promotional submissions documents in the database.
• Develop SOPs and training for Ad/Prom review.
• Escalate issues related to MLR reviews as needed.
• Drive consistency and operational excellence.

Skills

Regulatory leadership

FDA regulations knowledge

Regulatory submissions

Cross-functional leadership

English communication

Problem solving

Matrixed organization

Attention to detail

Education

Advanced degree preferred

Job description

Genetix Biotherapeutics seeks a Director of Regulatory Advertising & Promotion to lead U.S. regulatory activities for promotional materials across the portfolio. You will partner with Medical Affairs, Commercial, Marketing and Legal to ensure compliant strategies and timely health authority submissions.

The role requires 10+ years in biotech/pharma regulatory, with strong MLR and FDA experience, and excellent communication in a matrixed organization.