Director of Regulatory Advertising & Promotion

Genetix Biotherapeutics; Boston (MA); Hybrid; USD 185,000 - 285,000; Full time

Benefits offered by this job

Health insurance

Life & disability insurance

401(k) plan

Tuition reimbursement & loan repayment

Paid parental leave

Paid onsite parking

Commuter subsidy

Flexible time-off + holidays

Job summary

Genetix Biotherapeutics is seeking 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 align promotional strategies with regulatory requirements. The role requires 10+ years in biotech/pharma regulatory environments, with strong MLR and FDA experience, and a track record of cross-functional leadership in a matrixed organization.

Qualifications

• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree) 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.
• 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.
• Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines.

Responsibilities

• Oversee regulatory review of US promotional materials across channels for compliance with FDA rules.
• Lead MLR reviews with Medical-Legal-Regulatory teams.
• Collaborate with Commercial, Medical Affairs and Legal to mitigate regulatory risk.
• Monitor FDA enforcement actions and translate insights into internal guidance.
• Develop submission strategies for health authority reviews and ensure timely submissions.
• Create and manage submission documents in the electronic database.

Skills

Regulatory leadership

FDA promotional compliance

MLR review

Cross-functional leadership

Regulatory strategy

Risk assessment

Communication excellence

Education

Advanced degree (PharmD/PhD/MD/JD)

Job description

Genetix Biotherapeutics is seeking 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 align promotional strategies with regulatory requirements. The role requires 10+ years in biotech/pharma regulatory environments, with strong MLR and FDA experience, and a track record of cross-functional leadership in a matrixed organization.