Regulatory Advertising & Promotion Director, Gene Therapy

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

Job summary

Genetix Biotherapeutics Inc. seeks a Director/Sr. Director, US Regulatory Advertising & Promotion to lead US regulatory activities for promotional materials across the portfolio.

The role partners with Medical Affairs, Commercial, Marketing, and Legal to ensure compliance with FDA requirements, develop submission strategies, and drive review processes in a cell and gene therapy context. Hybrid work from Somerville, MA with onsite 3 days weekly.

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, including leadership without direct authority.
• Deep understanding of FDA regulations and guidance governing promotional materials.
• 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.

Responsibilities

• 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.
• 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.

Skills

Regulatory leadership

Cross-functional leadership

FDA regulations

MLR review

Promotional compliance

Education

PharmD/PhD/MD/JD or equivalent

Job description

Genetix Biotherapeutics Inc. seeks a Director/Sr. Director, US Regulatory Advertising & Promotion to lead US regulatory activities for promotional materials across the portfolio.

The role partners with Medical Affairs, Commercial, Marketing, and Legal to ensure compliance with FDA requirements, develop submission strategies, and drive review processes in a cell and gene therapy context. Hybrid work from Somerville, MA with onsite 3 days weekly.