Director, US Regulatory Advertising & Promotion

Adweek; 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 time off

Tuition reimbursement

Job summary

Genetix Biotherapeutics in Somerville, MA, is seeking a Director, US Regulatory Advertising & Promotion to lead regulatory review of promotional materials across the portfolio, ensuring FDA compliance and alignment with corporate objectives.

You will partner with Medical Affairs, Commercial, Marketing and Legal to review materials, manage MLR processes, and guide submission strategies for health authorities in a fast-paced cell and gene therapy setting.

Qualifications

• Advanced degree (PharmD, PhD, MD, JD or equivalent) preferred, but not required.
• 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.

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 mitigate regulatory risk in promotional strategy and execution.
• Monitor FDA enforcement actions and policy developments related to advertising and translate insights into internal guidance.
• Develop submission strategy for health authority review of promotional materials and ensure timely submissions.
• Create and manage promotional submissions documents in the electronic database with Regulatory Operations.

Skills

Regulatory leadership

Cross-functional leadership

FDA regulatory knowledge

MLR review

Strategic thinking

Communication skills

Problem solving

Leadership without authority

Education

PharmD or equivalent

Advanced degree

Job description

Genetix Biotherapeutics in Somerville, MA, is seeking a Director, US Regulatory Advertising & Promotion to lead regulatory review of promotional materials across the portfolio, ensuring FDA compliance and alignment with corporate objectives.

You will partner with Medical Affairs, Commercial, Marketing and Legal to review materials, manage MLR processes, and guide submission strategies for health authorities in a fast-paced cell and gene therapy setting.