Remote Director, Regulatory Affairs and Advertising Promotion

Summary

Join our team at Ultragenyx and make a difference for those who need it most as the Director of Regulatory Affairs Ad/Promo. This role involves serving as a subject matter expert for regulatory review, providing leadership to the Materials Review Committee, and ensuring compliance with applicable laws and regulations.

Requirements

• Requires a BA/BS degree; advanced degree preferred (PharmD, PhD, MS, MBA, JD)
• 10+ years of industry experience including 5+ years of advertising promotion experience
• Excellent verbal and written communication skills
• Attention to detail and ability to manage multiple priorities simultaneously
• Strong interpersonal skills with ability to demonstrate strategic and analytical thinking
• Demonstrate and proactively advocate working together in the spirit of transparency that encourages engagement, collaboration, and respectful interactions
• Experience chairing/leading review committees or other relevant regulatory governance committees
• Experience participating in cross-functional projects and teams
• Strong interpersonal skills and understanding of team dynamics

Responsibilities

• Serve as the MRC Chair and provide direction and regulatory expertise for promotional materials, medical, and payer communications
• Serve as primary contact with the FDA (OPDP/APLB) and PAAB as needed, including responding to agency inquiries and managing company requests for advisory review of advertising and promotional material
• Review and approve Form FDA-2253 submissions
• Provide strategic and operational regulatory guidance on new concepts, campaigns, and product labeling to help ensure promotional materials are aligned with promotional regulations, corporate standards, and policies and business objectives
• Support the U.S. and CA commercial and medical teams, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on strategies and objectives and tactics
• Maintain current awareness of evolving agency regulations and interpretations, FDA advisory letters, enforcement letters and policy issues and trends affecting the industry; communicate significant changes in Agency perspective to relevant stakeholders
• May lead cross-functional process improvements or other special projects
• Represent Regulatory Affairs Ad/Promo at regulatory sub-team and labeling meetings; provide strategic regulatory guidance

Benefits

• Generous vacation time
• Public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans