About the job
The Director of Regulatory Affairs - Advertising & Promotion at ITF Therapeutics leads the regulatory review and strategy for commercial communications. Reporting to the Head of Portfolio Strategy & Chief of Staff, this role shapes how the company approaches advertising and promotion, especially in support of rare disease therapies. The director partners with teams across the organization to ensure all materials meet regulatory requirements and reflect company values.
Main Responsibilities
- Review and approve marketing materials to ensure compliance with FDA regulations and internal standards.
- Represent regulatory affairs on the promotional review committee (MLR), working with Marketing, Medical Affairs, and Legal/Compliance.
- Facilitate committee discussions and help stakeholders reach agreement on promotional content.
- Serve as the in-house expert on FDA advertising and promotion regulations, sharing insights on enforcement trends.
- Lead efforts to keep teams updated on regulatory or policy changes that affect promotional strategies.
- Manage communications with the Office of Prescription Drug Promotion (OPDP), including regulatory submissions and responses to inquiries.
- Inform stakeholders about label changes and how they impact promotional and medical materials.
- Maintain strong communication with Medical, Marketing, Regulatory, Legal, and other internal groups.
- Provide training on FDA advertising and promotion rules for employees and agents.
- Support the development of U. S. labeling strategies to ensure compliance in promotional activities.
Location
This position is based in Concord, MA.