Director/Sr. Director, US Regulatory Advertising and Promotion

This is a full-time hybrid position based in our Somerville, Massachusetts (Assembly Row) office, with an onsite presence required three days per week. Candidates must reside within a commutable distance of the office to be considered.

 Position Description:

The Director/Sr. Director, Regulatory Advertising & Promotion is responsible for leading U.S. advertising and promotion regulatory activities across the company’s portfolio. This role provides strategic and operational leadership to ensure promotional materials are compliant with regulatory requirements and aligned with corporate and commercial objectives.

The Director serves as a key regulatory partner to Medical Affairs, Commercial, Marketing, and Legal, and plays a central role in promotional material review in a highly regulated environment, for cell and gene therapy products.

Job Duties and Responsibilities:

Advertising and Promotion

• 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.

Governance, Process and Compliance

• 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.

Essential/Required 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, including leadership without direct authority.
• Deep understanding of FDA regulations and guidance governing promotional materials
• An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts.
• 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.
• Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines, motivates others, demonstrates tact and diplomacy, and has a flexible and positive solution-oriented approach.