Associate Director, Regulatory Affairs - Advertising & Promotion
Xeris Pharmaceuticals, Inc.
July 01, 2026
Remote friendly (Chicago, IL)
United States
Corporate Functions
Responsibilities:
- Lead development and oversight of processes/procedures for creation, review, and approval of advertising and promotional materials to ensure regulatory compliance.
- Support processes for creation, review, and internal approval of FDA-approved prescribing information, Medication Guides, and patient labeling.
- Review external communications, sales/marketing materials (including training) for compliance with current regulations/guidance.
- Train sales and marketing personnel on advertising/promotion procedures, best practices, and FDA guidance/trends.
- Represent the company with customers/agencies and present on regulatory issues related to advertising/promotion.
- Manage regulatory aspects of the copy review/approval process; ensure promotional materials comply with FDA laws/regulations/guidance.
- Contribute to corporate policies/procedures for regulation of promotional materials and external communications.
- Develop/maintain SOPs for review, approval, and submission of advertising/promotional materials; partner with Legal, Medical Affairs, and Commercial to improve the review system.
- Coordinate and train employees on regulatory issues for product promotion.
Qualifications:
- BS in scientific discipline; advanced degree preferred.
- 7+ years of Regulatory Affairs experience focused on advertising/promotional regulations.
- Direct experience communicating/negotiating with OPDP; experience performing risk assessments.
- Experience developing/executing global regulatory strategies and communicating risk/benefit to senior management.
- Labeling development and lifecycle management experience.
- Strong knowledge of US FDA regulations/guidance for advertising/promotional materials (Drugs, Biologics, Medical Devices).
- AI technologies or AI-enabled process improvements (highly desirable).
Working conditions:
- Periodic evening/weekend work; periodic overnight travel; Chicago office (min. 2 days/week).
Compensation:
- Anticipated base salary range: $174,000–$232,000.
Application instructions:
- For reasonable accommodations, email recruiting@xerispharma.com with the job requisition number (no medical/health details).
- Lead development and oversight of processes/procedures for creation, review, and approval of advertising and promotional materials to ensure regulatory compliance.
- Support processes for creation, review, and internal approval of FDA-approved prescribing information, Medication Guides, and patient labeling.
- Review external communications, sales/marketing materials (including training) for compliance with current regulations/guidance.
- Train sales and marketing personnel on advertising/promotion procedures, best practices, and FDA guidance/trends.
- Represent the company with customers/agencies and present on regulatory issues related to advertising/promotion.
- Manage regulatory aspects of the copy review/approval process; ensure promotional materials comply with FDA laws/regulations/guidance.
- Contribute to corporate policies/procedures for regulation of promotional materials and external communications.
- Develop/maintain SOPs for review, approval, and submission of advertising/promotional materials; partner with Legal, Medical Affairs, and Commercial to improve the review system.
- Coordinate and train employees on regulatory issues for product promotion.
Qualifications:
- BS in scientific discipline; advanced degree preferred.
- 7+ years of Regulatory Affairs experience focused on advertising/promotional regulations.
- Direct experience communicating/negotiating with OPDP; experience performing risk assessments.
- Experience developing/executing global regulatory strategies and communicating risk/benefit to senior management.
- Labeling development and lifecycle management experience.
- Strong knowledge of US FDA regulations/guidance for advertising/promotional materials (Drugs, Biologics, Medical Devices).
- AI technologies or AI-enabled process improvements (highly desirable).
Working conditions:
- Periodic evening/weekend work; periodic overnight travel; Chicago office (min. 2 days/week).
Compensation:
- Anticipated base salary range: $174,000–$232,000.
Application instructions:
- For reasonable accommodations, email recruiting@xerispharma.com with the job requisition number (no medical/health details).