Specialty/Senior Specialty Representative - Bone Health - Dallas/Arlington, TX (Overlay)

Director-level role overseeing promotional regulatory strategy for respiratory products at a pharmaceutical company. Responsibilities include regulatory review of promotional materials across multiple channels, FDA engagement, cross-functional partnership, and team leadership to ensure compliant brand execution.

Responsibilities

• Drive regulatory review and risk assessment of promotional materials across HCP, consumer, and managed markets segments
• Lead regulatory strategy development, risk identification, and contingency planning to enable compliant brand storytelling
• Serve as primary liaison with FDA OPDP/APLB for assigned brands and manage advisory requests and enforcement actions
• Develop and deliver regulatory training; build capability across commercial and medical teams
• Manage, mentor, and develop less experienced staff; shape departmental vision and operational practices

Requirements

• Bachelor's degree in science
• 3+ years promotional regulatory affairs, FDA OPDP/APLB, or equivalent advertising/promotion review experience
• 5+ years total pharmaceutical, biotech, FDA, or equivalent industry experience
• Strong knowledge of FDA promotional regulations and diverse material review
• Knowledge of drug development and labeling processes